RES11078 CONTROL PATIENTS Book: Blank Case Report

Blank Case Report Form for Study: RES11078

Book: CONTROL PATIENTS

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COMMON SUBJECT ASSESSMENT (CSA) Date of completion ______Participant: (CASE= Case, CNTL= Control, FAM= Family Member) CRF Version _ Complete by site staff before handing to study participant for Items 1-15

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COMMON SUBJECT ASSESSMENT Continued Medical and Family History These questions are about you and your health. There are no right or wrong answers. You can put 'Don't Know'. Most people take 5 to 15 minutes to complete, but take as much time as you need. Feel free to ask the study staff if you need help or have questions. Section 1 - Your Information Please fill in boxes: 1. Date of birth ______2. Please put your sex. __ (M= Male , F= Female) 3. Are you adopted? __ (Y= Yes, N= No, K= Don't know)

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COMMON SUBJECT ASSESSMENT Continued Section 2 - You and Your Family's Origins The following is about you, your parents and grandparents if related by blood (for example, your biological parents, but NOT your step-parents). 4. For You SL SELF Race _ (W= White, B= Black, A= Asian, X= Other). Other, specify ______Your first Language(s) 1. ______(EN= English, FR= French, GE= German, 2. ______HL= Dutch, IT= Italian, X= Other). 'Asian', here, means from India, Pakistan, Far east, Southeast Asia, Pacific Rim. 'Other', here, means your group is not shown above, or is a combination of groups. Please put your group on the text field.

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Blank Case Report Form for Study RES11078

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COMMON SUBJECT ASSESSMENT Continued 5. For each of your 2 parents, tick box The following groups have some genetic importance or boxes if relevant and fill in the blank. in understanding disease. If your parents are from any of these groups, please tick 1 or more boxes Your Parents Race Other, specify First language? Other, specify Ethnic Group M BIOLOGICAL MOTHER ______F BIOLOGICAL FATHER ______(W=White, B=Black, A=Asian, (EN= English, FR= French, (FN= Finnish, FRCD= French Canadian, K= Don't Know, X= Other) HNSA= Hispanic from North, South or Central America, ASJW= Ashkenazi Jewish, M= North America 'Asian', here, means from India, Pakistan, Far East, Southeast Asia, Pacific Rim. 'Original Peoples' or First Nation) 'Other', here, means the group of your parents is not show above, or is a combination of groups.

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COMMON SUBJECT ASSESSMENT Continued 6. For each of your 4 grandparents, tick box or boxes if relevant and fill in the blank. The following groups have some genetic importance in understanding disease If your grandparents are from any of these groups, please tick 1 or more boxes Your Biological Grandparents Race Other, specify First language? Other, specify Ethnic group MGM MATERNAL GRANDMOTHER ______MGF MATERNAL GRANDFATHER ______PGM PATERNAL GRANDMOTHER ______PGF PATERNAL GRANDFATHER ______(W- White, B= Black, A=Asian, (EN= English, (FN= Finnish, FRCD= French Canadian K=Don't Know, X= Other) FR= French, HNSA= Hispanic from North, South or Central America, ASJW= Ashkenazi Jewish, M= North American 'Original Peoples' or First Nation)

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COMMON SUBJECT ASSESSMENT Continued 7. Have you, or your immediate family (parents, brothers, sisters or children) ever been told by a doctor about having the following illnesses? Please tick for each illness, one box under the column labelled 'You' and one under the column labelled 'Your Parents, Brothers, Sisters or Children? Your Parents, Brothers, If so, how Sisters or MANY had Illness You Children the illness? Allergies * ARHF HAYFEVER _ _ __ ALDR DRUG ALLERGY _ _ __ Bone or Joint Problems ODB OSTEOPOROSIS OR 'THIN' BONES _ _ __ OSA OSTEOARTHRITIS _ _ __ RART RHEUMATOID ARTHRITIS _ _ __ ARTO OTHER ARTHRITIS _ _ __ Lung or Breathing ATH ASTHMA _ _ __ Problems ECB EMPHYSEMA OR CHRONIC BRONCHITIS _ _ __ Heart or Circulation MIAN HEART ATTACK, ANGINA _ _ __ Problems HCL HIGH BLOOD CHOLESTEROL _ _ __ HBP HIGH BLOOD PRESSURE _ _ __ ST STROKE _ _ __ (Y= Yes, N= No) (Y= Yes, N= No K= Don't Know)

* Drugs causing allergies ______

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Blank Case Report Form for Study RES11078

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COMMON SUBJECT ASSESSMENT Continued 7. Have you, or your immediate family (parents, brothers, sisters or children) ever been told by a doctor about having the following illnesses? Please tick for each illness, one box under the column labelled 'You' and one under the column labelled 'Your Parents, Brothers, Sisters or Children? Your Parents, If so, how Brothers, Sisters MANY had Illness You or Children the illness? Digestive Problems IB INFLAMMATORY BOWEL DISORDER (CROHNS, ULCERATIVE COLITIS) _ _ __ Diabetes DB1 DIABETES TYPE 1 (EARLY ONSET) _ _ __ DB2 DIABETES TYPE 2 (LATE ONSET) _ _ __ DBNR PAIN DUE TO DIABETES (DIABETIC NEUROPATHY) _ _ __ PHN PAIN DUE TO VIRUS (POST HERPETIC NEURALGIA) _ _ __ Mood Disorders ANX ANXIETY OR PANIC DISORDER _ _ __ BPD MANIC DEPRESSION OR BIPOLAR DISORDER _ _ __ OCB OBSESSIVE/COMPULSIVE DISORDER _ _ __ DLM DEPRESSION THAT NEEDS TREATMENT _ _ __ DLMP DEPRESSION AFTER PREGNANCY (POST-PARTUM DEPRESSION) _ _ __ Nervous System EPCV EPILEPSY OR CONVULSIONS _ _ __ Problems MGR MIGRAINE HEADACHES _ _ __ MS MULTIPLE SCLEROSIS _ _ __

PD PARKINSON'S DISEASE _ _ __ MEML SEVERE MEMORY LOSS (LIKE ALZHEIMER'S DISEASE) _ _ __ SCH SCHIZOPHRENIA _ _ __ (Y=Yes, (Y=Yes, N=No, N=No) K=Don't Know)

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COMMON SUBJECT ASSESSMENT Continued 7. Have you, or your immediate family (parents, brothers, sisters or children) ever been told by a doctor about having the following Brothers, Sisters or Children? Your Parents, Brothers, If so, how Sisters or MANY had Illness You Children the illness? Cancer BRCN BREAST CANCER _ _ __ LCNR LUNG CANCER _ _ __ SC STOMACH CANCER _ _ __ CC COLON CANCER _ _ __ UC UTERUS CANCER _ _ __ PCNR PROSTATE CANCER _ _ __ Skin Diseases PSOR PSORIASIS _ _ __ Put Other X OTHER _ _ __ Illness NOT X OTHER _ _ __ Listed above X OTHER _ _ __ Specify other illnesses 1. ______2. ______3. ______

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COMMON SUBJECT ASSESSMENT Continued 8. Did you ever in your life drink 5 or more drinks of any kind of alcohol almost every day? _ (Y=Yes, N=NO, K= Don't know) 8a. Do you drink alcohol now? (Y= Yes, N= No) If NO, go to question 9 8b. During the past 30 days, on how many days did you have at least one alcohol drink?

( NONE= [None], 1B5D [1 to 5 days ], 5B10D [ 5 to 10 days ], >10D [ more than 10 days ] ) 'One drink' means a bottle of beer, or a large glass of wine, or a single spirit measure of liquor. 8c. Over the last 30 days, what is the average number of drinks you had PER DAY: ___ 9. Tick the box that best descr be you: _ (S= I smoke now, If F "I don't smoke now', then F= I don't smoke now. I have stopped smoking for ____ Years N= I have never smoked) If N, go to question 10 9a. About how many cigarettes do you or did you smoke per day? _____ (CD= Cigarettes per day, PD= Packs per day) __ 9b. Put the number of years you have smoked ____ Years

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COMMON SUBJECT ASSESSMENT Continued 12. How many cups (or cans) of drinks with caffeine do you have per day? ( NONE [None], 1B3 [1 to 3], 4B6 [4 to 6], >6 [more than 6] ) 13. Has the doctor ever told you that you were overweight? _ (Do not include times during pregnancy) (Y= Yes, N= No, K= Don't know) If yes, then put what ages (in years) that you were overweight? You can tick more than one box. (Y= Yes, N= No) <10Y YOUNG CHILD, 10 YEARS OR LESS _ 11B19Y TEENAGER, 11 TO 19 YEARS _ 20B30Y YOUNG ADULT, 20 TO 30 YEARS 31B50Y ADULT, 31 TO 50 YEARS _ >50Y OLDER ADULT, MORE THAN 50 YEARS 14. Are you concerned about your memory because it affects how you work or the way you live from day to day?

If yes, has your memory problem gotten worse in the last year? _ (Y= Yes, N= No, K= Don't know) 15. How many years did you go to school? ____ ( <4Y [Less than or equal to 4 years], 5B10Y [5 to 10 years], 11B15Y [11 to 15 years], >15Y [more than 15 years] )

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Blank Case Report Form for Study RES11078

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METHOD OF ASCERTAINMENT Recruitment through a clinic visit? _ (Y=Yes, N=No) If YES, choose one from either the Specialty clinic OR General clinic ___ Specialty clinic Prospective (new patient to this specialty clinic) (SP) Retrospective (return patient to this specialty clinic) (SR) General or other clinic Prospective (new patient to this clinic) (PG) Retrospective (return patient to this clinic) (RG) Recruitment through a referral? _ (Y=Yes, N=No) If YES, select one from either Physician-referral, Genetic-referral OR Self-referral: ___ Physician-referral Self-referral Primary Care (PC) Response to advertisements (AD) Disorder related specialist (DS) Response to school survey (SS) Other specialist (OS) Referral from relative or acquaintance (RA) Genetic-referral Other self-referral (S) Genetic professional (GP) Recruitment from an existing study? _ (Y=Yes, N=No) If YES, select one from this group: Previous or ongoing study of this disease (POD) Previous or ongoing study of another disease (POA) Disease registry (DR) Previous Genetic Study (PGS) Other, specify (X) ______

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CONTROLS AND UNAFFECTED SIBLINGS ONLY INCLUSION CRITERIA ( Y=Yes, N=No ) 1 Does this participant have a MMSE score higher than the cut off score? (once age and education adjusted) 2 Does this participant have a AEMSS score of 9 or higher? _ (age and education adjusted) 3 Does this participant have a clock test score of >= 14? _ 4 Does this participant have no impairment of the 7 Instrumental ADL _ questions from OARS, unless explained by a physical disability? 5 Is the participant Caucasian? _ Additional Inclusion for unaffected sibling only 6 Is the participant 65 years of age or older? _ If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

EXCLUSION CRITERIA (Y=Yes, N=No) 1 Is this participant currently in a Major Depressive Episode, _ Psychosis, acute mania or depressive episode of Bipolar Disorder? 2 Does this participant have cognitive impairment on testing? _ 3 ** Question deleted on updated CRF ** _ 4 Is this participant classified as an MCI patient? _

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INFORMED CONSENT Date consent (Y=Yes, N=No) obtained Version 1 Has the participant given his/her consent to participate in the study? ______3 Has this participant/proxy given consent for future brain autopsy? ______Please ensure the participant is given a copy of the signed consent form to keep

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CLASSIFICATION OF PARTICIPANT This participant meets the inclusion/exclusion criteria for: CNTL = Control ____ UFAM = Unaffected Biological Relative Relationship to Index Case Family number: What is the Subject ID of the index case to which this family member is related? Index case (AD participant) Subject ID: What is the participants relationship to the index case? Other specify ______

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Country of Origin What is the participants country of origin? (not necessarily country of birth) ____ ( CD = Canada, UK = United Kingdom, FR = France, X = Other, K = Don't know ) Specify if other ______

Country of Origin What is the country of origin of participants family? (not necessarily country of birth) Relationship to subject Country of origin Other, specify ______( CD = Canada, UK = United Kingdom, FR = France, X = Other, K = Don't know )

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Anthropometry / Vital Signs Exam Assessment Date ______Weight _____ KG Height _____ CM Waist circumference ___ CM 5 minute Sitting Blood Pressure MmHg Sitting Heart Rate Respiration Systolic / diastolic Beats / min Breaths / min

Regular or Irregular ___ (Y=Regular, N=Irregular) NOTE: If blood pressure is 160/90 or greater or if there is an irregular heart rate +1 other cardiovascular symptom, please complete Brief Neurological Exam.

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BRIEF NEUROLOGICAL EXAM/DIAGNOSTIC OPINION PARTICIPATION All cases, e.g. patients with Alzheimer's disease Controls and family members with a positive answer in the section No. 3 of the CSA (medical history) to: *stroke *2 of 4 for: hear attack/angina, high blood cholesterol, high blood pressure and irregular pulse *diabetes type 1 or 2 *epilepsy/convulsions *multiple sclerosis *Parkinson's disease *severe memory loss *breast, lung or stomach cancer Controls and family members with a BP above 160/90 on vital signs. Exam assessment date ______Present / Absent Specify, if present CB 1. CAROTIS BRUITS ______2. Limb rigidity RILP a) PARATONIA ______RILO b) LIMB RIGIDITY-OTHER ______3. Gait/posture FG a) FRONTAL GAIT ______PRK b) PARKINSONISM ______GOTH c) GAIT/POSTURE-OTHER ______4. Tremor TRP a) TREMOR-POSTURAL ______TRR b) TREMOR-RESTING ______TRO c) TREMOR-OTHER ______5. Frontal release signs FRSG a) FRONTAL RELEASE SIGNS-GRASP ______FRSO b) FRONTAL RELEASE SIGNS-OTHER ______6. Others eg. myoclonus, bradykinesia * OTH OTHER ______*Other specify ______

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Normal / Abnormal Specify, if abnormal DTR 1. DEEP TENDON REFLEXES ______PLR 2. PLANTAR RESPONSES ______Can be conducted within 3 month time period of blood sampling. Based on all available evidence, my opinion is that this person has: Probable AD _ (Y=Yes, N=No) Is functionally and cognitively intact? (Y=Yes, N=No) Medical Doctors Name ______Date _ ____

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Current Medications Prescription Medications Is the participant taking any Prescription medication? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Drug name Frequency Date started Date stopped ongoing ESTROGEN REPLACEMENT THERAPY ______( REG=Regular, Mon-YY Mon-YY PRN=PRN ) i.e. Jul-02 i.e. Jul-02

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Current Medications (continued) Vitamins Is the participant taking any Vitamins? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Drug name Frequency Date started Date stopped ongoing Reason VITAMIN E ______(Generic name preferred) ______( REG=Regular, Mon-YY Mon-YY PRN=PRN ) i.e. Jul-02 i.e. Jul-02

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Current Medications (Continued) Herbals / Over the counter Is the participant taking any Herbal Medications / OTCs? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Drug name Frequency Date started Date stopped ongoing Reason GINKO BILOBA ______LECITHIN ______IBUPROFEN (ADVIL) ______ASPIRIN ______TYLENOL ______(Generic name preferred) ______( REG=Regular, MON-YY MON-YY PRN=PRN ) i.e. JUN-02 i.e. JUN-02

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Mini Mental Exam Status Assessment date _ ___ Raw MMSE Total score __ Cut off score (age and education adjusted) Raw score is: ( ON=On, BL=Below, AB=Above cut off ) Scale Scores Raw score ORIENTATION ___ MEMORY ___ ATTENTION ___ LANGUAGE ___ PRAXIS ___ CONSTRUCTION ___ Specify any corrections that may modify the MMSE Total Score ______Note: If the MMSE is >= 15 (all controls and unaffected siblings and mildly impaired AD patients) the DRS2 should be completed. If the MMSE is < 15 (moderate to severely impaired patients) the SIB should be completed.

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DRS2 (Complete only if MMSE >= 15) Assessment Date ______Scale Scores: Raw score MOANS Score ATTENTION _____ INITIATION/PERSEVERATION ______CONSTRUCTION ______CONCEPTUALIZATION ______MEMORY ______AEMSS TOTAL ______

OARS Assessment Date ______OARS Total score __ ( Y=Yes, N=No ) Unable to demonstrate due to physical disability Other specify ______

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OARS Assessment Date ______A. CAN YOU USE THE TELEPHONE _ 0 = Completely Unable, 1 = with some help, 2 = without help B. CAN YOU GET TO PLACES OUT OF WALKING DISTANCE _ C. CAN YOU GO SHOPPING FOR YOUR GROCERIES OR CLOTHES _ D. CAN YOU PREPARE YOUR OWN MEALS _ E. CAN YOU DO YOUR HOUSEWORK _ F. CAN YOU TAKE YOUR OWN MEDICINE _ G. CAN YOU HANDLE YOUR OWN MONEY _

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Clock Scale Assessment Date ______Command Copy INTEGRITY OF THE CLOCKFACE (0-2 EACH) __ /2 __ /2 PRESENCE AND SEQUENCING OF NUMBERS (0-4 EACH) __ /4 __ /4 PRESENCE AND PLACEMENT OF HANDS (0-4 EACH) __ /4 __ /4 TOTAL __ /10 __ /10 TOTAL CLOCK SCALE _____ /20

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Last Meal before Blood Draw: When: __ (TD = Today, YD = Yesterday) Time of meal (00:00 - 23:59) What: ___ (LB = Light Breakfast like drink and toast, FB = Full Breakfast like bacon and eggs, LM = Light Meal like drink and sandwich, FM = Full Meal like meat, starch, and vegetables)

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Visit_Name : LABS Visit_Date:

Laboratory Results Lab codes: Montreal: 1006 Vancouver: 1007 London: 1008 Date Blood Sample taken ______DD-MON-YY, i.e. 15-JUN-2002 Time of Blood Sample _____ 24 hour clock, i.e. 13:50 Sample acquisition number ______Blood test Result Units CHOL ______MMOL/L HDLCH ______MMOL/L LDLCH ______MMOL/L TRIG ______MMOL/L WBC ______GIGA/L HB ______G/L HBA1C ______%

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End of Study Record Withdrawal Record Was the subject withdrawn from the study? (Y= Yes, N= No) If yes, date of withdrawal: ______DD-MMM-YY i.e. 15-JUN-02 State the reason, ______

BLOOD SAMPLE DESTRUCTION Has a request been made for sample destruction? (Y=Yes, N=No) If YES, tick one reason: _ (R=Subjects Request, X=Other) Specify ______Date of request for blood sample destruction?

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CONTROLS AND UNAFFECTED SIBLINGS ONLY INCLUSION CRITERIA ( Y=Yes, N=No ) 1 Did this participant take part in the initial GenADA study as a control _ or unaffected sibling? 2 Has this participant given informed consent to take part in this _ follow-up study? 3 Is the participant appropriately matched to a GENADA-LONG _ case or is showing signs of cognitive decline? If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Exclusion Criteria Yes/No 1 Is the participant currently in a major depressive episode, _ psychosis, or acute manic depressive episode or bipolar disorder? If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this study.

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Autopsy Has the participant died ? _ (Y=Yes, N=No) (If 'NO" please proceed to the Informed Consent) If "YES", Date of death ______Has an autopsy been performed ? _ (Y=Yes, N=No) (If 'NO" please finish the questionaire HERE) Date of autopsy ______Autopsy result __ (N=Normal, P=Probable AD, NA=Not available, X=Other) If other, specify ______

INFORMED CONSENT Date consent (Y=Yes, N=No) obtained version 1 Has the participant given his/her consent to participate in this follow-up study ? ______3 Has a relative consented to the release of the autopsy information? ______Please ensure that the participant is given a copy of the signed consent form to keep.

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Has the participant given permission to be contacted again? _ Y=Yes, N=No If "NO", specify reason for refusal: _ Other specify ______

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INFORMED CONSENT (Y=Yes, N=No) 4 Has the participant agreed to give a blood and urine sample? _ Please ensure the participant is given a copy of the signed consent form to keep

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Visit_Name : CSA2 Visit_Date:

COMMON SUBJECT ASSESSMENT (CSA) Have you, or your immediate family (parents, brothers, sisters or children) ever been diagnosed with any of the following since your last visit ? Please tick for each illness, one box under the column labeled 'You' and one under the column labeled 'Your Parents, Brothers, Sisters or Children? Assessment Date __ __ Your Parents, Brothers, If so, how Sisters or MANY had Illness You Children the illness? Allergies * ARHF HAYFEVER _ _ __ ALDR DRUG ALLERGY _ _ __ Bone or Joint ODB OSTEOPOROSIS OR 'THIN' BONES _ _ __ Problems OSA OSTEOARTHRITIS _ _ __ RART RHEUMATOID ARTHRITIS _ _ __ ARTO OTHER ARTHRITIS _ _ __ Lung or Breathing ATH ASTHMA _ _ __ Problems ECB EMPHYSEMA OR CHRONIC BRONCHITIS _ _ __ Heart or Circulation MIAN HEART ATTACK, ANGINA _ _ __ Problems HCL HIGH BLOOD CHOLESTEROL _ _ __ HBP HIGH BLOOD PRESSURE _ _ __ ST STROKE _ _ __ Digestive Problem IB1 INFLAMMATORY BOWEL DISORDER (CROHNS, ULCERATIVE COLITIS) _ _ __

Diabetes DB1 DIABETES TYPE 1 _ _ __ DB2 DIABETES TYPE 2 _ _ __ DBNR PAIN/NUMBNESS DUE TO DIABETES (DIABETIC NEUROPATHY) _ _ __ (Y= Yes, N= No) (Y= Yes, N= No * Drugs causing allergies ______K= Don't Know)

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COMMON SUBJECT ASSESSMENT (CSA) Continued Have you, or your immediate family (parents, brothers, sisters or children) ever been diagnosed with any of the following since your last visit ? Please tick for each illness, one box under the column labeled 'You' and one under the column labeled 'Your Parents,Brothers, Sisters or Children? Your Parents, If so, how Brothers, Sisters MANY had Illness You or Children the illness? Mood ANX ANXIETY OR PANIC DISORDER _ _ __ Disorders BPD MANIC DEPRESSION OR BIPOLAR DISORDER _ _ __ OCB OBSESSIVE/COMPULSIVE DISORDER _ _ __ DLM DEPRESSION THAT NEEDS TREATMENT _ _ __ DLMP DEPRESSION AFTER PREGNANCY (POST-PARTUM DEPRESSION) _ _ __ Nervous System EPCV EPILEPSY OR CONVULSIONS _ _ __ Problems MGR MIGRAINE HEADACHES _ _ __ MS MULTIPLE SCLEROSIS _ _ __ PD PARKINSON'S DISEASE _ _ __ MEML SEVERE MEMORY LOSS (LIKE ALZHEIMER'S DISEASE) _ _ __ SCH SCHIZOPHRENIA _ _ __ PHN PAIN DUE TO VIRUS (POST HERPETIC NEURALGIA) _ _ __ Cancer BRCN BREAST CANCER _ _ __ LCNR LUNG CANCER _ _ __

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SC STOMACH CANCER _ _ __ CC COLON CANCER _ _ __ UC UTERUS CANCER _ _ __ PCNR PROSTATE CANCER _ _ __ Skin Disease PSOR PSORIASIS _ _ __ Other Illness NOT X OTHER _ _ __ Listed Above X OTHER _ _ __ X OTHER _ _ __ (Y=Yes, (Y=Yes, N=No, N=No) K=Don't Know) Specify Other Illiness: ______

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COMMON SUBJECT ASSESSMENT Continued 1a. Do you drink alcohol now? __ (Y= Yes, N= No) If NO, go to question 2. 1b. During the past 30 days, on how many days did you have at least one alcohol drink? _____ 'One drink' means a bottle of beer, or a large glass of wine, or a single spirit measure of liquor. 1c. Over the last 30 days, what is the average number of drinks you had PER DAY: (S= I smoke now, 2. Tick the box that best descr be you: V= I have stopped smoking since my last study visit A= None of the above) 3. How many cups (or cans) of drinks with caffeine do you have per day? ____ ( NONE [None], 1B3 [1 to 3], 4B6 [4 to 6], >6 [more than 6] ) 4. Are you concerned about you memory, because it affects _ (Y= Yes, N= No) how you work or the way you live from day to day ? If "YES", has your memory problem worsened since your _ last study visit ?

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CLASSIFICATION OF PARTICIPANT Date of consent at previous study visit ______

This participant is classified as: ____ (CNTL= Control, USAB= Unaffected S bling )

Date of birth: _ ___ Sex: __ (M= Male , F= Female)

Is the participant a primary caregiver for a dependant? _ (Y = Yes, N = No)

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CLASSIFICATION OF PARTICIPANT Continued FAMILY HISTORY Problems Diagnosed with Type of Relationship with memory? * Dementia? dementia to subject If other, specify (Y = Yes, N = No, K = Don't Know) (A = AD, O = Other) If other, specify ______* Sufficient to cause a problem to the person such that they needed some form of help or their poor memory was a concern to others.

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ANTHROPOMETRY / VITAL SIGNS Exam assessment date __ Weight (Without shoes and coat) : _____ KG Not done _ (N = Not Done) Height: CM Not done _ (N = Not Done) Waist circumference: CM Not done (N = Not Done) Birth Weight: ____ KG Don't know _ (K = Don't know) Birth Size: _ (S = Small, N = Normal, L = Large, K = Don't Know) When were you born relative to your due date? (P = Premature, D = Post Date, O = On Time, K = Don't Know) 5 minute Sitting Blood pressure mmHg Sitting Heart Rate Respiration Systolic / Diastolic Beats / min Breaths / min ___ / ______Is Heart Rate Regular? (Y = Regular, N = Irregular) Additional General Features Ambulatory __ (AM = Ambulatory, AA = Ambulatory with assistance, NA = Non-Ambulatory)

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Visit_Name : VISIT 2 Visit_Date:

Current Medications Prescription Medications

Is the participant taking any prescription medications? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Day of last Time of last

Drug name Dose Unit Frequency dose? medicine dose Date started ESTROGEN REPLACEMENT THERAPY ______(mg = milligrams, (1D = Once a Day, 00:00 - 23:59 Mon-YY Mon-YY g = grams) 2D = Twice a Day, i.e. Jul-02 i.e. Jul-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Current Medications (continued) Vitamins Is the participant taking any Vitamins? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Drug name Day of last Time of last (Generic name preferred) Dose Unit Frequency dose? dose Date started Date stopped

VITAMIN E ______FOLIC ACID ______(mg = milligrams, (1D = Once a Day, 00:00 Mon-YY Mon-YY g = grams) 2D = Twice a Day, 23:59 i.e. Jul-02 i.e. Jul-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Visit_Name : VISIT 2 Visit_Date:

Current Medications (Continued) Herbals / Over the counter

Is the participant taking any Herbal Medications / OTCs? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Day of last Time of last Drug name Dose Unit Frequency dose? medicine dose Date started Date stopped

GINKO BILOBA ______LECITHIN ______IBUPROFEN (ADVIL) ______ASPIRIN ______TYLENOL ______(Generic name preferred)

______(mg = milligrams, (1D = Once a Day, 00:00 MON-YY MON-YY g = grams) 2D = Twice a Day, 23:59 i.e. JUN-02 i.e. JUN-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Mini Mental Status Exam (All Participants) Assessment date __ Raw MMSE Total score __ Scale Scores Raw score ORIENTATION ___ MEMORY ___ ATTENTION ___ LANGUAGE ___ PRAXIS ___ CONSTRUCTION ___ Specify any corrections that may modify the MMSE Total Score Specify ______NOTE: If DRS2 was completed at the previous visit and the SIB is now required, please complete both the DRS2 and SIB for this visit only.

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Patient: ______Site: Investigator:

Visit_Name : VISIT 2 Visit_Date:

Assessment Date __ ___ Scale Scores: Raw score MOANS Score AEMSS ATTENTION __ INITIATION/PERSEVERATION ______CONSTRUCTION ______CONCEPTUALIZATION ______MEMORY Total ______DRS2 total raw score at last visit Percent (%) difference in total raw score __ If greater than or equal to 10 percent (%) reduction in raw score, participant is now considered a CONTROL WITH CHANGE IN COGNITIVE STATUS Please complete: - Logical Memory test - Global Deterioration Scale

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Logical Memory Test (for controls with change in cognitive status only) Scoring Summary Assessment Date ______Logical Memory 1 STORY A RECALL UNIT SCORE ____ STORY A THEMATIC UNIT SCORE ____ STORY B 1ST RECALL UNIT SCORE ____ STORY B 1ST RECALL THEMATIC UNIT SCORE ____ 1ST RECALL TOTAL SCORE ____ (Story A Recall Unit Score + Story B Recall Unit Score) STORY B 2ND RECALL UNIT SCORE ____ STORY B 2ND RECALL THEMATIC UNIT SCORE ____ RECALL TOTAL SCORE ____ (Sum Recall Unit Scores for Story A, Story B-1st, Story B-2nd) THEMATIC TOTAL SCORE ____ (Sum Thematic Unit Scores for Story A, Story B-1st, Story B-2nd) LEARNING SLOPE CALCULATION ____ (Story B-2nd Recall Unit Score - Story B-1st Recall Unit Score)

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Logical Memory Test (for controls with change in cognitive status only) Logical Memory 2 STORY A RECALL UNIT SCORE ____ STORY A THEMATIC UNIT SCORE ____ STORY B RECALL UNIT SCORE ____ STORY B THEMATIC UNIT SCORE ____ RECALL TOTAL SCORE ____ (Story A Recall Unit Score + Story B Recall Unit Score) THEMATIC TOTAL SCORE ____ (Story A Thematic Unit Score + Story B Thematic Unit Score) PERCENT RETENTION ____ [(Logical Memory II Recall Total Score)/(Logical Memory I Story A + Story B-2nd Recall Unit Score)] x 100

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Global Deterioration Scale (for controls with change in cognitive status only) Assessment Date ______Please tick the appropriate stage: __ ( 1 = No cognitive decline, 2 = Very mild cognitive decline, 3 = Mild cognitive decline, 4 = Moderate cognitive decline, 5 = Moderately severe cognitive decline, 6 = Severe cognitive decline, 7 = Very severe cognitive decline ) GDS Score _____

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OARS Scale Assessment Date ___ __

______OARS Total Score __ __ Today Previous Unable to demonstrate due to Physical Disability _ (Y=Yes, N=No) Other _ (Y=Yes, N=No) Specify ______

______F. CAN YOU TAKE YOUR OWN MEDICINE ______

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GERIATRIC DEPRESSION SCALE Assessment Date __ ___ How you felt over the last week Points for Response 1. ARE YOU BASICALLY SATISFIED WITH YOUR LIFE? _ (Yes = 0, No = 1) 2. HAVE YOU DROPPED MANY OF YOUR ACTIVITIES AND INTERESTS? _ (Yes = 1, No = 0) 3. DO YOU FEEL THAT YOUR LIFE IS EMPTY? _ (Yes = 1, No = 0) 4. DO YOU OFTEN GET BORED? _ (Yes = 1, No = 0) 5. ARE YOU IN GOOD SPIRITS MOST OF THE TIME? _ (Yes = 0, No = 1) 6. ARE YOU AFRAID THAT SOMETHING BAD IS GOING TO HAPPEN TO YOU? _ (Yes = 1, No = 0) 7. DO YOU FEEL HAPPY MOST OF THE TIME? _ (Yes = 0, No = 1) 8. DO YOU OFTEN FEEL HELPLESS? _ (Yes = 1, No = 0) 9. DO YOU PREFER TO STAY AT HOME, RATHER THAN GOING OUT AND DOING NEW THINGS? _ (Yes = 1, No = 0) 10. DO YOU FEEL YOU HAVE MORE PROBLEMS WITH MEMORY THAN MOST? _ (Yes = 1, No = 0) 11. DO YOU THINK IT IS WONDERFUL TO BE ALIVE NOW? _ (Yes = 0, No = 1) 12. DO YOU FEEL PRETTY WORTHLESS THE WAY YOU ARE NOW? _ (Yes = 1, No = 0) 13. DO YOU FEEL FULL OF ENERGY? _ (Yes = 0, No = 1) 14. DO YOU FEEL THAT YOUR SITUATION IS HOPELESS? _ (Yes = 1, No = 0) 15. DO YOU THINK THAT MOST PEOPLE ARE BETTER OFF THAN YOU ARE? _ (Yes = 1, No = 0) Total Score __ Interpretation _ (N = Normal, B = Borderline, D = Depression)

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CEREBROVASCULAR EXAMINATION Bilateral Carotid Ultrasound Examination Has a doppler assessment of carotid atherosclerosis been carried out? (Y = Yes, N = No) If "YES", please specify results (indicating laterality, which vessels are involved i.e., common, external and/or internal carotid and percentage/degree of carotid artery stenosis) ______

THROMBO-EMBOLIC RISK FACTORS Does the participant have any of the following thrombo-embolic risk factors? (Y / N / k) If "YES", provide details CARDIAC ARRHYTHMIAS ______VALVULAR HEART DISEASE ______HISTORY OF RHEUMATIC FEVER / RHEUMATIC HEART DISEASE ______PROSTHETIC HEART VALVES ______CARDIAC SURGERY OR CABG ______HISTORY OF SUBACUTE OR ACUTE INFECTIVE ENDOCARDITIS ______HISTORY OF VASCULITIS ______OTHER AUTO-IMMUNE CONDITIONS ______PROTHROMBOTIC CONDITIONS ______

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BRIEF NEUROLOGICAL EXAM/DIAGNOSTIC OPINION Participation Controls and unaffected siblings with a positive answer in the section of the CSA (medical History) to: * stroke * 2 of 4 for: heart attack/angina, high blood cholesterol, high blood pressure and irregular pulse on vital signs. * diabetes type 1 or 2 * epilepsy/convulsions * multiple sclerosis * Parkinson's disease * severe memory problem * breast, lung or stomach cancer - Controls and unaffected siblings with a BP above 160/90 on vital signs. - Controls with change in congnitive status Exam assessment date ______Present / Absent Specify, if present including laterality CB 1. CAROTID BRUITS ______2. Limb rigidity RILP a) PARATONIA ______RILO b) OTHER ______3. Gait/posture FG a) FRONTAL GAIT ______PRK b) PARKINSONISM ______GOTH c) AMBULATORY ______TRP d) OTHER ______4. Tremor TRR a) POSTURAL ______TRO b) RESTING ______FRSG c) OTHER ______5. Frontal release signs FRSO a) GRASP ______OTH b) OTHERS ______6. Others e.g., MYOC MYOCLONUS, BRADYKINESIA ______

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Normal / Abnormal Specify, if abnormal DTR 1. DEEP TENDON REFLEXES ______PLR 2. PLANTAR RESPONSES ______

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Brief Neurological Exam/Diagnostic Opinion Hachinski Ischaemic Scoring System Item Enter all that apply ABRUPT ONSET _ (Enter 2 if item applies) STEPWISE DETERIORATION _ (Enter 1 if item applies) FLUCTUATING COURSE _ (Enter 2 if item applies) NOCTURNAL CONFUSION _ (Enter 1 if item applies) PRESERVATION OF PERSONALITY _ (Enter 1 if item applies) DEPRESSION _ (Enter 1 if item applies) SOMATIC COMPLAINTS _ (Enter 1 if item applies) EMOTIONAL INCONTINENCE _ (Enter 1 if item applies) HISTORY OF HYPERTENSION _ (Enter 1 if item applies) HISTORY OF STROKE _ (Enter 2 if item applies) ASSOCIATED ATHEROSCLEROSIS _ (Enter 1 if item applies) FOCAL NEUROLOGICAL SYMPTOMS _ (Enter 2 if item applies) FOCAL NEUROLOGICAL SIGNS _ (Enter 2 if item applies) Total Score (Maximum of 18)* __ * The total score is consistent with MID (multi-infarct dementia) if it is 7 or greater and with AD if it 4 or less. A score of 5 to 6 may suggest AD plus CVD. Based on all available evidence, my opinion is that this person: Is functionally and cognitively intact? Y = Yes, N = No Doctor's Name ______Date ______

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BRIEF NEUROLOGICAL EXAM/DIAGNOSTIC OPINION CONTINUED Final Diagnosis: Still a control ? (Y = Yes, N = No) If "NO", specify reason for change: Reason for change (NI = Neuroimaging, NP =Neuropsychology, OT =Other) If other, specify ______Causes of Dementia Y / N (Y = Yes, N = No) AD _ VaD _ DLB _ PD _ FTD _ OTHER _ MIXED AD/VAD _ Other specify ______CIND subclasses Y / N (Y = Yes, N = No) AMNESTIC _ EARLY DEGENERATIVE (NON-AD) _ VASCULAR _ NEUROLOGICAL _ PSYCHIATRIC _ MEDICAL AND TOXIC METABOLIC DISORDERS _ OTHER (MIXED/NON SPECIFIED ETC.) _ Domain (To be completed by neuropsychologist / psychometrician) Amnestic Single Domain Multiple Domain _

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BRIEF NEUROLOGICAL EXAM/DIAGNOSTIC OPINION CONTINUED (for previous controls who have converted to AD) Diagnosis of Alzheimer's Disease Date of (Any) Physician's Diagnosis of AD ______ie;15-MAY-1996 Age at physician's diagnosis (years) Age of onset of first symptoms noted by family/friends (years) Duration of known symptoms of AD __ (years) Was the patient diagnosed with MCI prior to AD? (Y = Yes, N = No, K = Don't Know) If "YES", in what year was MCI diagnosis made ? ____ (year) Other features available on history: (Y = Yes, N = No UA = Unavailable) EARLY/PROMINENT VISUOSPATIAL IMPAIRMENT __ If YES, specify: ______EARLY SPEECH ABNORMALITIES __ If YES, specify: ______EARLY EXECUTIVE ABNORMALITIES __ If YES, specify: ______EARLY APRAXIA __ If YES, specify: ______

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Visit_Name : IMAGE2 Visit_Date:

Neuroimaging (Only for controls with change in cognitive status) 1 Site participating in imaging substudy? _ Y=Yes, N=No 2 If NO, is imaging data available from other source? _ Y=Yes, N=No Informed Consent Yes/No Date 1 Has the participant given his/her consent to participate in imaging sub-study? ______Please ensure that the participant is given a copy of the signed consent form to keep.

Inclusion Criteria Y=Yes, N=No 1 Has the participant consented to visit 1 of the GENADA-LONG study _ as control ? 2 Is this participant classified as a control with change in _ cognitive status? 3 Is the participant able to provide an adequate baseline scan? _ If any INCLUSION CRITERIA question is answered NO, the subject must NOT enter this neuroimaging substudy

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Exclusion Criteria Y=Yes, N=No 1 Does the participant have any contraindication to scanning such as _ pacemaker, ferrous metal implants or claustrophobia? 2 Does the participant suffer from uncontrolled epilepsy, seizures, or blackouts? _ Has the participant failed to give an adequate baseline acquisition after two 3 separate baseline visits? _ If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this neuroimaging substudy.

Date of MRI scan ______Scan should be within 6 weeks of GENADA-LONG visit Was the participant able to provide the following: Y=Yes, N=No 1 Two (2) T1 weighted MRI (volumetric) scans _ 2 One (1) T2 weighted MRI (vascular) scan _

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Neuroimaging (To be completed from MRI Scan Report) A) Has the participant completed the Baseline MRI Scan? _ Y= Yes, N=No If "NO" please specify reason ______If YES, complete below. If NO, complete below for most informative previous scan available. Date of Baseline MRI scan/Most Informative CT/MRI scan ______Imaging type ___ CT, MRI

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Neuroimaging (To be completed from MRI Scan Report) B) According to this scan, does the participant have Global Atrophy? _ Y=Yes, N=No If "YES", go to section D) below C) According to this scan, does the participant have Focal Atrophy Y=Yes, N=No, K=Don't Know If YES, select: D) According to this scan, does the participant have Infarcts? _ Y=Yes, N=No, K=Don't Know If "YES", please complete below Cortical ____ Lacunar/deep ____ E) According to this scan, does the participant have White Matter Change? _ Y=Yes, N=No, K=Don't Know If YES, please select: ______Other: Specify ______

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Neuroimaging Continued Site not taking part in imaging substudy therefore not assessed _ Y=Yes, N=No If Yes do not complete the form below. Please proceed to next page. Date of MRI scan ______Wahlund Score for White Matter Changes 1 Frontal _ 0, 1, 2, 3 2 Parieto-occipital _ 0, 1, 2, 3 3 Temporal _ 0, 1, 2, 3 4 Infratentorial _ 0, 1, 2, 3 5 Basal Ganglia 0, 1, 2, 3 Total Score (Sum of regions 1-5) __ (Maximum score 15) Qualitative Assessment of Periventicular White Matter 1 Dense Bands _ P = Present, A = Absent 2 Thin Caps _ P = Present, A = Absent 3 Thick Caps _ P = Present, A = Absent 4 Smooth Halo _ P = Present, A = Absent

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Visit_Name : LABS 2R Visit_Date:

Last Meal before Blood Draw: When: __ (TD = Today, YD = Yesterday, Not Applicable(fasting for more than 48 hours)) Time of meal _____ (00:00 - 23:59) What: ___ (LB = Light Breakfast like drink and toast, FB = Full Breakfast like bacon and eggs, LM = Light Meal like drink and sandwich, FM = Full Meal like meat, starch, and vegetables)

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Meal Information for Metabolomics When was your Amount of last serving Serving Type last serving? How Often (within 48 hrs) CT COFFEE OR TEA ______Cup(s) B CAFFEINE CONTAINING BEVERAGES ______Cup(s) EGT EARL GREY TEA ______Cup(s) AL ALCOHOL ______Cup(s) G GRAPEFRUIT ______serving(s) F FISH ______serving(s) BN BANANAS ______serving(s) CH CHEESE ______serving(s) Servings, according to Canada's Food Guide Grapefruit = 1 grapefruit = 1 serving Cheese = 50 grams = 1 serving Banana = 1 banana = 1 serving Fish = 50 - 100 grams = 1 serving

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Laboratory Results Blood test Result Units ______

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Visit_Name : STUDY END2 Visit_Date:

End of Study Record Withdrawal Record Was the subject withdrawn from the study? (Y= Yes, N= No) If yes, date of withdrawal: __ __ DD-MMM-YY i.e. 15-JUN-02 State the reason, ______

BLOOD SAMPLE DESTRUCTION Has a request been made for sample destruction? _ (Y=Yes, N=No) If YES, tick one reason: _ (R=Subjects Request, X=Other) Specify ______Date of request for blood sample destruction? ______NOTE: If the subject has been withdrawn at this visit, DO NOT contact for any future follow-up visits

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CLASSIFICATION OF PARTICIPANT Date of consent at previous study visit ______

CLASSIFICATION OF PARTICIPANT At time of last visit, what home type was participant in ? (N = Nursing home, O = Own home) Home Type Currently: _ (N = Nursing home, O = Own home) If participant is currently in a nursing home: Date of first admission into nursing home: ______

This participant is classified as: ____ (CNTL= Control, USAB= Unaffected S bling, CCCS=Control w/Change in Cognitive Status )

Date of birth: ______Sex: __ (M= Male , F= Female) Is the participant a primary caregiver for a dependant ?

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ANTHROPOMETRY / VITAL SIGNS Anthropometry Exam assessment date ______Weight (Without shoes and coat) : _____ KG _ (N = Not Done) Height: _____ CM _ (N = Not Done) Waist circumference: ___ CM _ (N = Not Done) Vital Signs 5 minute Sitting Blood pressure mmHg Sitting Heart Rate Respiration Systolic / Diastolic Beats / min Breaths / min ___ / ______Is Heart Rate Regular? _ (Y = Regular, N = Irregular) NOTE: If blood pressure is 160/90 or greater or if there is an irregular heart rate +1 other cardiovascular symptom, please complete the Brief Neurological Exam. Additional General Features __ (AM = Ambulatory, AA = Ambulatory with assistance, NA = Non-Ambulatory)

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Current Medications Prescription Medications

Is the participant taking any prescription medications? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Day of last Time of last

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PT: ______INVSITE:: INV:

Visit_Name : VISIT 3 Visit_Date:

VITAMIN E ______FOLIC ACID ______(mg = milligrams, (1D = Once a Day, 00:00 Mon-YY Mon-YY g = grams) 2D = Twice a Day, 23:59 i.e. Jul-02 i.e. Jul-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Visit_Name : VISIT 3 Visit_Date:

Current Medications (Continued) Herbals / Over the counter

GINKO BILOBA ______LECITHIN ______IBUPROFEN (ADVIL) ______ASPIRIN ______TYLENOL ______(Generic name preferred)

______(mg = milligrams, (1D = Once a Day, 00:00 MON-YY MON-YY g = grams) 2D = Twice a Day, 23:59 i.e. JUN-02 i.e. JUN-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Visit_Name : VISIT 3 Visit_Date:

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Patient: ______Site: Investigator:

Visit_Name : VISIT 3 Visit_Date:

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OARS Scale Assessment Date ___ __

______OARS Total Score __ __ Today Previous Unable to demonstrate due to Physical Disability _ (Y=Yes, N=No) Other _ (Y=Yes, N=No) Specify ______

______F. CAN YOU TAKE YOUR OWN MEDICINE ______

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Laboratory Results Blood test Result Units ______

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CONTROLS AND UNAFFECTED SIBLINGS ONLY INCLUSION CRITERIA ( Y=Yes, N=No ) 1 Did this participant take part in the last GenADA-Long visit as a control or _ unaffected s bling? 2 Has the participant agreed to be contacted for this follow-up visit? _ 3 Has this participant given informed consent to take part in this follow-up visit? _ If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

EXCLUSION CRITERIA (Y=Yes, N=No) 1 Has the participant withdrawn their participation in _ GenADA/GenADA-Long? 2 Is the participant currently in a major depressive episode, _ psychosis, or acute manic depressive episode of bipolar disorder? If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this study.

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Visit_Name : ELIG3 Visit_Date:

Autopsy Has the participant died ? _ (Y=Yes, N=No) If "NO", please proceed to INFORMED CONSENT If "YES", Date of Death ___ Has an autopsy been performed ? _ If "NO", please finish questionnaire HERE Date of autopsy ______Autopsy result __ (P=Probable AD, NA=Not available, X=Other) If other, specify ______

INFORMED CONSENT Date consent (Y=Yes, N=No) obtained Version 1 Has the participant given his/her consent to participate in this follow-up study? ______2 If autopsy performed, has a relative consented to the release of the autopsy information? ______Please ensure that the participant is given a copy of the signed consent form to keep.

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INFORMED CONSENT (Y=Yes, N=No) 4 Has the participant agreed to give a blood and urine sample? _ Please ensure the participant is given a copy of the signed consent form to keep

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Visit_Name : BNE3 Visit_Date:

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Normal / Abnormal Specify, if abnormal DTR 1. DEEP TENDON REFLEXES ______PLR 2. PLANTAR RESPONSES ______

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Visit_Name : IMAGE3 Visit_Date:

Inclusion Criteria Y=Yes, N=No 1 Has the participant consented to visit 2 of the GENADA-LONG study _ as control ? 2 Is this participant classified as a control with change in _ cognitive status? 3 Was the participant able to provide an adequate baseline scan? _ 4 Is the participant able to provide an adequate scan _ at this visit? If any INCLUSION CRITERIA question is answered NO, the subject must NOT enter this neuroimaging substudy

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Visit_Name : IMAGE3 Visit_Date:

Exclusion Criteria Y=Yes, N=No 1 Does the participant have any contraindication to scanning such as _ pacemaker, ferrous metal implants or claustrophobia? 2 Does the participant suffer from uncontrolled epilepsy, seizures, or blackouts? _ 3 Has the participant failed to give an adequate acquisition after two _ separate visits? If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this neuroimaging substudy.

Date of MRI scan ______Scan should be within 6 weeks of this GENADA-LONG visit Was the participant able to provide the following: Y=Yes, N=No 1 One (1) T1 weighted MRI (volumetric) scans _ 2 One (1) T2 weighted MRI (vascular) scan _

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Visit_Name : IMAGE3 Visit_Date:

Neuroimaging (To be completed from MRI Scan Report) A) Has the participant completed the Visit 2 MRI Scan? _ Y= Yes, N=No If "NO" please specify reason ______If YES, complete below. If NO, complete below for most informative previous scan available. Date of Visit 2 MRI scan/Most Informative CT/MRI scan ______Imaging type CT, MRI

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Visit_Name : LABS 3R Visit_Date:

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Visit_Name : STUDY END3 Visit_Date:

End of Study Record Withdrawal Record Was the subject withdrawn from the study? (Y= Yes, N= No) If yes, date of withdrawal: __ __ DD-MMM-YY i.e. 15-JUN-02 State the reason, ______

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PLEASE COMPLETE THE FOLLOWING PAGES FOR A SUBJECT THAT WAS CONSIDERED A CONTROL WITH A CHANGE IN COGNITIVE STATUS AT THEIR PREVIOUS VISIT Caregiver/Informant Details Sex of Caregiver/Informant _ Relationship to subject If OTHER, please specify ______How long have you known the subject? How often you see the subject? _____

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Visit : CCCS Visit Date: _Name _

NEUROPSYCHIATRIC INVENTORY QUESTIONNAIRE Assessment Date ______For each domain: - If the screening question did not apply, enter "Y" under the N/A column. - If the screening question was negative, enter "0" under the Absent / Severity column. - If the screening question was positive, enter value for Severity and Caregiver Distress. - Total all Severity and Distress score and record in the Total Score boxes below. Severity scale: 0=absent, 1=mild severity, 2=moderate severity, 3=severe Caregiver Distress scale: 0=no distress, 1=minimal, 2=mild,3=moderate, 4=moderately severe, 5= very severe / extreme. Absent / Caregiver Domain N/A Severity Distress A) DELUSIONS __ _ _ B) HALLUCINATIONS __ _ _ C) AGITATION/AGGRESSION __ _ _ D) DEPRESSION/DYSPHORIA __ _ _ E) ANXIETY __ _ _ F) ELATION/EUPHORIA __ _ _ G) APATHY/INDIFFERENCE __ _ _ H) DISINHIBITION __ _ _ I) IRRITABILITY/LIABILITY __ _ _ J) ABERRANT MOTOR BEHAVIOR __ _ _ TOTAL SCORE: __ __ K) SLEEP AND NIGHTTIME BEHAVIOR DISORDER _ _ _ L) APPETITE AND EATING DISORDERS _ _ _ Blank Case Report Form for Study RES11078

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Visit_Name : CCCS Visit_Date:

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Visit_Name : CCCS Visit_Date:

NOTE: If the DRS2 was completed at the previous visit and the SIB is now required, please complete both the DRS2 and SIB for this visit only. SIB (Complete only if MMSE is <15) Assessment Date ___ __ Raw SIB Total score: ___ Scale Scores: Raw score SOCIAL INTERACTION __ MEMORY __ ORIENTATION __ LANGUAGE __ ATTENTION __ PRAXIS __ VISUOSPATIAL ABILITY __ CONSTRUCTION __ ORIENTATING TO NAME __

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THE BARTHEL INDEX Only to be completed in cases who have a GDS score 5,6, or 7 at THIS GenADA-LONG visit. Assessment Date __ ___ Assessment Time _____ 00:00 - 23:59 Please choose the appropriate score for each activity Feeding (0 = unable, 5 = needs help cutting, spreading butter, etc., or requires modified diet, 10 = independent) Bathing (0 = dependent, 5 = independent (or in shower)) Grooming (0 = needs to help with personal care, 5 = independent face / hair / teeth / shaving (implements provided)) Dressing __ (0 = dependent, 5 = needs help but can do about half unaided, 10 = independent (including buttons, zips, laces, etc.)) Bowels __ (0 = incontinent (or needs to be given enemas), 5 = occasional accident, 10 = continent) Bladder __ (0 = incontinent, or catheterized and unable to manage alone, 5 = occasional accident, 10 = continent) Toilet Use __ (0 = dependent, 5 = needs some help, but can do something alone, 10 = independent (on and off, dressing, wiping))

CONFIRMATION OF ALZHEIMER'S DISEASE Continued THE Barthel Index (continued) Transfers __ (0 = unable, no sitting balance, 5 = major help (one or two people, physical), can sit, 10 = minor help (verbal or physical), (bed to chair and back) 15 = independent) Mobility __ (0 = immobile or < 50 yards, 5 = wheelchair independent, including corners, > 50 yards, 10 = walks with help of one (on level surfaces) person (verbal or physical) > 50 yards, 15 = independent (but may use any aid; for example, stick) > 50 yards) Stairs (0 = unable, 5 = needs help (verbal, physical, carrying aid), 10 = independent) Total Score ___ (0-100)

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DSM-IV Diagnosis of Dementia of the Alzheimer's Type: Specify Code: ______290.10: with early onset, uncomplicated 290.11: with early onset, with delirium 290.12: with early onset, with delusions 290.13: with early onset, with depressed mood 290.0: with late onset, uncomplicated 290.3: with late onset, with delirium 290.20: with late onset, with delusions 290.21: with late onset, with depressed mood

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Previous Neuropsychological and Neurocognitive Tests Previous Neuropysychological or Neurocognitive test results available since last visit? ( Y=Yes, N=No ) If yes, please specify below Please enter the most recent score Test Name Test Date Raw score Interpretation MMSE ______( IMP=Impaired, CLOCK ______NOT=Not Impaired, SIB ______NA = N/A ) TRAIL A ______TRAIL B ______MDRS / DRS-2 ______OARS ______Other Tests ______

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CLASSIFICATION OF PARTICIPANT Date of consent at previous study visit ______

This participant is classified as: ____ (CNTL= Control, USAB= Unaffected S bling, CCCS=Control w/Change in Cognitive Status )

Date of birth: ______Sex: __ (M= Male , F= Female) Is the participant a primary caregiver for a dependant ?

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Current Medications Prescription Medications

Is the participant taking any prescription medications? _ ( Y=Yes, N=No, K=Don't Know ) If 'YES', Please enter details into the table below Day of last Time of last

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VITAMIN E ______FOLIC ACID ______(mg = milligrams, (1D = Once a Day, 00:00 Mon-YY Mon-YY g = grams) 2D = Twice a Day, 23:59 i.e. Jul-02 i.e. Jul-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Current Medications (Continued) Herbals / Over the counter

GINKO BILOBA ______LECITHIN ______IBUPROFEN (ADVIL) ______ASPIRIN ______TYLENOL ______(Generic name preferred)

______(mg = milligrams, (1D = Once a Day, 00:00 MON-YY MON-YY g = grams) 2D = Twice a Day, 23:59 i.e. JUN-02 i.e. JUN-02 3D = Thrice a Day, PRN = As Needed, X = Other)

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Visit_Name : VISIT 4 Visit_Date:

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OARS Scale Assessment Date ___ __

______OARS Total Score __ __ Today Previous Unable to demonstrate due to Physical Disability _ (Y=Yes, N=No) Other _ (Y=Yes, N=No) Specify ______

______F. CAN YOU TAKE YOUR OWN MEDICINE ______

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Laboratory Results Blood test Result Units ______

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Visit_Name : ELIG4 Visit_Date:

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INFORMED CONSENT (Y=Yes, N=No) 4 Has the participant agreed to give a blood and urine sample? _ Please ensure the participant is given a copy of the signed consent form to keep

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Visit_Name : CSA4 Visit_Date:

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Visit_Name : BNE4 Visit_Date:

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Normal / Abnormal Specify, if abnormal DTR 1. DEEP TENDON REFLEXES ______PLR 2. PLANTAR RESPONSES ______

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Visit_Name : IMAGE4 Visit_Date:

Inclusion Criteria Y=Yes, N=No 1 Has the participant consented to visit 3 of the GENADA-LONG study _ as control ? 2 Is this participant classified as a control with change in _ cognitive status? 3 Was the participant able to provide an adequate baseline scan? _ 4 Is the participant able to provide an adequate scan _ at this visit? If any INCLUSION CRITERIA question is answered NO, the subject must NOT enter this neuroimaging substudy

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Exclusion Criteria Y=Yes, N=No 1 Does the participant have any contraindication to scanning such as _ pacemaker, ferrous metal implants or claustrophobia? 2 Does the participant suffer from uncontrolled epilepsy, seizures, or blackouts? _ 3 Has the participant failed to give an adequate acquisition after two _ separate visits? If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this neuroimaging substudy.

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Neuroimaging (To be completed from MRI Scan Report) A) Has the participant completed the Visit 3 MRI Scan? _ Y= Yes, N=No If "NO" please specify reason ______If YES, complete below. If NO, complete below for most informative previous scan available. Date of Visit 3 MRI scan/Most Informative CT/MRI scan ______Imaging type CT, MRI

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Visit_Name : LABS 4R Visit_Date:

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Visit_Name : STUDY END4 Visit_Date:

End of Study Record Withdrawal Record Was the subject withdrawn from the study? (Y= Yes, N= No) If yes, date of withdrawal: __ __ DD-MMM-YY i.e. 15-JUN-02 State the reason, ______

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Visit_Name : CCCS4 Visit_Date:

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Visit : CCCS4 Visit Date: _Name _

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Visit_Name : CCCS4 Visit_Date:

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Patient: ______Site: Investigator:

Visit_Name : CCCS4 Visit_Date:

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