A9951002 PF-04360365 in patients with Alzheimer's disease
A phase II multicenter, randomized, double blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of multiple doses of PF-04360365 in patients with mild to moderate Alzheimer's Disease
Anthony Peter Passmore
This study aims to assess the effects of a new medicine PF-04360365 in patients with Alzheimerâ€™s disease (AD). This medicine is being developed by Pfizer (a pharmaceutical company) who are funding the study and it is being run in 6 countries including the UK. The aim of the study is to work towards developing a medicine that may slow the progression and treat the symptoms of AD. The medicine may or may not help patients with AD during this study. Each patient will be assigned to one of 3 doses levels or a placebo (a placebo contains no active ingredients). The new medicine will be compared with placebo, and the patient will have a 25% (one in four) chance of receiving placebo. This study will also look at how PF-04360365 is handled by the body by measuring its levels in the blood during and after the administration. Patients will be screened to assess eligibility. If deemed eligible, patients will be enrolled in the study. Patients will receive 10 doses of PF-04360365 or placebo in hospital via intravenous infusion, given over approximately 2 hours. During the drug administration the patient will have continuous cardiac monitoring and close observation by medical and nursing staff. Blood samples will be taken regularly for assessing the safety of the medicine and to see how much of PF-04360365 is in their blood. Other tests will be done including ECGâ€™s, vital signs, physical and neurological examinations and cognitive tests to check memory and thinking. Patients will remain post study drug administration up to 8 hours. After the patientâ€™s last dose they will be followed up for the next six months and similar tests will be done at each visit. There will be 24 visits over two years.
South Central - Hampshire A Research Ethics Committee
Date of REC Opinion
21 Oct 2008
Further Information Favourable Opinion