TMU Coordinators Call Minutes 07/24/2007

TMU Call Minutes 01/22/2008

Present Columbia: Marlene Carlson and Fred Jarskog Duke: Mike Crouse and Joe McEvoy MGH/BIDMC (Harvard): Don Goff and Lisa Raeke MPRC: Pat Ball, Bob Buchanan, Jim Gold, Bob McMahon, and Chris Wells NIMH: Adam Haim NKI: Rosemary Coslit, Neikeisha Grenade, and Jim Robinson UCLA: Stephen Marder and Ayala Ofek Wash. U.: Myrtle Carter, John Csernansky, Emily Thomason and Pamela Voss

Action Items

Merck  Nothing to report

Allon  Nothing to report

Avera  Don Goff – Send DSMB correspondence to Pat Ball  Pat Ball – Send out DSMB correspondence to sites

Biovalve  Nothing to report

Epix  Nothing to report

All Protocols  Bob Buchanan – Sent out ranges for vitals.  All sites – Should send back CS and NCS ranges for vitals to Pat Ball.

Site Monitoring Visit  Nothing to report

Merck  Site Recruitment review  All sites approved with Inclusion/Exclusion criteria amendment (Columbia pending) Allon  Site Recruitment review

Avera  DSMB report is available for IRBs  Not all sites may be required to report  If needed please obtain correspondence from Pat Ball

Biovalve  Nothing to report

Epix  Developed serotonine 6 receptor antagonist  Created originally for weightloss  Found to improve cognition  Would like to develop protocol to test this  Currently deciding on proper dosage to examine in study  Resultant of negative effects found in 2nd study  Study utilized CANTAB battery  Ok in low dose (300/600mg once daily)  Worse then placebo results for high dose (600mg twice daily)  Drug may possess U-shaped response curve  May be phenomena associated due to confound from illness  fMRI study may not explain results and will take ~one year to complete  “Proof of Concept” study preferred using 300, 600 and 900mg  Face-to-face meeting may be best way to discuss matters with Epix

All Protocols  Vitals  Abnormal reading flag entries with error  While some entries may be abnormal, the abnormal level may not be clinically significant (or clinically significant)  Database cannot differentiate between vitals that are out of range and “clinically significant” or “not clinically significant”  Pulse, Respiration and EKG should be adjusted to include readings that are “not clinically significant”  CS ranges that require no action will need a note to file included in the subjects file.  If new sites are being added to expand recruitment base, please be sure to update 1572s

Site Monitoring Visit  Nothing to report

Next Coordinators call: January 29, 2008 Next TMU call: February 12, 2008