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Safety, Tolerability, and Feasibility of Young Plasma

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Safety, Tolerability, and Feasibility of Young Plasma Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) 1 1 Abbreviations and Definitions AE Adverse Event CRF Case Report Form CTCAE Common Terminology Criteria for Adverse Events IMP Investigational Medical Product SAP Statistical Analysis Plan 2 2 Introduction 3 2.1 Preface 4 The Plasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously- 5 Administered Plasma from Young Donors for Treatment of Mild-To-Moderate 6 Alzheimer’s Disease 7 2.2 Purpose of the analyses 8 These analyses will assess 1) number of subjects with adverse events as a 9 measure of safety and tolerability and number of subjects who comply with 10 the research protocol as a measure of feasibility 2) the neuropsychological, 11 functional and neuropsychiatric outcomes 3) other outcomes such as 12 functional connectivity assessed by resting state functional MRI, 13 compositional assessment of plasma, in vivo assessment of plasma 14 samples, and differential effect of outcomes related to ApoE genotype . 15 3 Study Objectives and Endpoints 16 3.1 Study Objectives 17 The objective of the study is to determine the safety and tolerability and feasibility 18 of once per week infusion of young plasma into this patient population and with 19 experimental endpoints to assess efficacy in cognition, behaviour and mood. 20 3.2 Endpoints 21 The primary outcome measure is the number of subjects with AEs as a measure of 22 safety and tolerability, and number of subjects who comply with the research 23 protocol as a measure of feasibility. Changes from baseline (as derived variables) in Page 1 of 29 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) 24 laboratory parameters (cbc, chemistry, liver function), vital signs, EKG, and physical 25 examination. 26 The secondary outcome measures are: 27 1) Change on the 13-item ADAS-Cog 28 2) Change on the Trail Making Test (TMT); Parts A and B 29 3) Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) 30 4) Change on the Functional Activities Questionnaire (FAQ) 31 5) Change on the Alzheimer’s Disease Cooperative Study Activities of Daily 32 Living Inventory in mild cognitive impairment (ADCS-MCI-ADL) 33 6) Change on the Geriatric Depression Scale (GDS) 34 7) Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q) 35 The other outcome measures are: 36 1) Change in functional connectivity in the default mode network as assessed 37 by resting state functional MRI 38 2) Compositional assessment of plasma using in vitro analytical methods. The 39 goal is to assess plasma components that might be associated with aging 40 and/or Alzheimer’s disease. These studies will focus initially on known 41 proteins (e.g. eotaxin, B2M, amyloid beta) but may extend to full plasma 42 proteome and other component (e.g. metabolites, lipids, nucleic acids) 43 profiling in the future. 44 3) In vivo assessment of plasma samples to determine their potential 45 histological effects on the hippocampus and their potential behavioral effects 46 in animal models of cognition. 47 4) Differential effect of therapy on above outcomes as a function of ApoE 48 genotype 49 3.3 Derived variables 50 Derived Boolean variables will be created from metabolic and hematologic labs as 1 51 or 0 indicating if there was a change from baseline. An AE is change in vital signs Page 2 of 29 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) 52 will be as follows: temperature >38.5 or <36.0 C, SBP >180 or <100 or 20% change 53 from baseline, DBP >110 or <40 or 20% change from baseline, HR >100 or <50 or 54 20% change from baseline, RR >24 or <10 or 20% change from baseline. 55 4 Study Methods 56 4.1 General Study Design and Plan 57 (ICH E3;9) 58 The study began in September 2014 as a double blind, cross 59 over, placebo (saline) controlled study. It was amended in October 2015 60 to a single arm open label study. After the amendment the 61 randomization assignment for all subjects in the original protocol 62 continued to be blinded to the investigator and 63 raters. Nine subjects were enrolled and treated under the double blind 64 crossover protocol with four weeks of weekly infusions of ~250mL of 65 plasma from 18-30 year-old male donors, followed by a 6-week washout 66 and then crossover to four weeks of weekly infusion of the alternate 67 treatment. An additional 9 subjects were enrolled and treated under 68 the open label amendment for four weeks with once weekly infusions of 69 ~250mL of plasma from male donors aged 18-30. 70 This is a randomized, blinded, cross-over study to determine the safety 71 and tolerability of once per week infusion of young male donor plasma in 72 subjects with AD. Starting within 2 weeks of Baseline Assessment: 73 o Blood draw: confirmation of ABO/Rh typing prior to first plasma 74 administration. 75 o Administer test agent (Young Male Donor Plasma or placebo saline) 76 once weekly for 4 weeks (+ day for each infusion), followed by 77 crossover to other test agent (placebo saline or Young Male Donor 78 Plasma) 79 o Concomitant medication review 80 o AEs review 81 o Journal review 82 Level and method of blinding: double-blind. 83 Method of treatment assignment: randomization 1:1. 84 85 o SCHEDULE OF EVENTS (09/2014) Page 3 of 29 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) Screening Block 1a Block 2b Close Visit #: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Week #: –2 0 1c 2c 3c 3d 9e 9f 10c 11c 12c 12d 18f Informed Consent X MMSE X Physical/Neurological X X X X X Exam Medication Review X X X X X Adverse Symptom X X X X Review Journal Review X X X X Randomization X ADAS-Cog-13 X X X X X Trail-Making Test X X X X X CDR X X X X X FAQ X X X X X ADCS-MCI-ADL X X X X X GDS X X X X X NPI-Q X X X X X Blood draw Xg Xh Xi Xh Xh Xi Xh Xh MRI X Xj Xj ECG X Infusion X X X X X X X X 86 aRandomization (1:1) of test agent to plasma or placebo prior to visit #3. 87 bTest agent assignment switches 88 c± 1 day, timed from the first infusion of the current block 89 d1–2 days after the last infusion 90 e1–2 days prior to visit #9 91 f± 3 days, timed from the day of the last infusion of the last block 92 gscreening laboratory tests to include: ABO/RH typing, infectious disease 93 screening (Human Immunodeficiency Virus, Hepatitus B, Hepatitus C), Page 4 of 29 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) 94 coagulation (Prothrombin Time, Partial Thromboplastin Time), urine pregnancy (if 95 applicable), metabolic and hematologic panels, blood for central banking 96 hmetabolic and hemtologic panels for safety monitoring 97 iconfirmation of ABO/RH type prior to plasma administration 98 jwithin 7 days after the last infusion, but ideally on the same day as the 99 neuropsychological assessment 100 Schedule of Events (10/15/2016) 101 Screening Infusions Close Visits Visit #: 1 2 3 4 5 6 7 8 a a a b c Week #: –2 0 1 2 3 3 7-9 Informed Consent X MMSE X Physical/Neurological X X X EConcomitantxam Medication X X X X X X X X Review Adverse Reaction X X X X X X RJouevrinaewl Review X X X X X X ADAS-Cog-13 X X X Trail-Making Test X X X CDR X X X FAQ X X X ADCS-MCI-ADL X X X GDS X X X NPI-Q X X X Digit Span X X X X X X X X Blood draw Xd Xe,f Xe Xe g MRI X X ECG X Infusion Xf Xf Xf Xf 102 103 a ± 1 day, timed from the first infusion 104 b 1-3 days after the last infusion 105 c 4-6 weeks after the last infusion d 106 screening laboratory tests to include: ABO/RH typing, infectious 107 disease screening (Human Immunodeficiency Virus, Hepatitis B, Hepatitis 108 C), coagulation (Prothrombin Time, Partial Thromboplastin Time), urine Page 5 of 29 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Statistical Analysis Plan The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA) 109 pregnancy (if applicable), metabolic and hematologic panels, blood for 110 central banking e 111 metabolic and hematologic panels for safety monitoring f 112 confirmation of ABO/RH type prior to plasma administration 113 gwithin 7 days of last infusion, but ideally on the same day as the 114 neuropsychological assessments 115 4.2 Equivalence or Non-Inferiority Studies 116 (ICH E3; 9.2, 9.7.1, 11.4.2.7. ICH E9; 3.3.2) 117 Not Applicable 118 4.3 Inclusion-Exclusion Criteria and General Study Population 119 (ICH E3;9.3. ICH E9;2.2.1) 120 4.3.1 Inclusion Criteria 121 Subjects are eligible for inclusion into the study if they met each of the following 122 criteria: 123 Aged 50-90 124 Diagnosis of probable Alzheimer's disease (NIA-AA criteria) 125 Mini-Mental State Examination (MMSE) score 12-24 126 Availability of a study partner who knows the patient well and is willing to 127 accompany the subject to all trial visits, to participate in questionnaires and to 128 complete daily journal assessments 129 4.3.2 Exclusion Criteria 130 Subjects are excluded from the study if they meet any of the following criteria: 131 Pregnancy or unwilling to use adequate birth control method for duration of and 132 6 months beyond study participation 133 Positive for Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at 134 screening 135 Any other condition or situation that the investigator believes may
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