Pfizer B2081011 - Phase 2a PF-05212377 safety& efficacy in Alzheimer’s
Research type
Research Study
Full title
A randomized, 18 week, Placebo Controlled, Double Blind Parallel Group Study of the Safety and Efficacy of PF-05212377 (SAM-760) in Subjects with Mild to Moderate Alzheimer’s Disease with Existing Neuropsychiatric Symptoms on a Stable Daily Dose of Donepezil.
IRAS ID
156125
Contact name
Roy William Jones
Contact email
Sponsor organisation
Pfizer Inc. 235 East 42nd Street, New York, 10017
Eudract number
2014-000830-42
Clinicaltrials.gov Identifier
Research summary
Alzheimer’s disease (AD) is the most common cause of dementia in elderly people and accounts for 60-70% of cases. AD is characterised by progressive deterioration in memory and other thinking processes such as language, judgement, planning, organising and reasoning. Current drug treatments are only symptomatic and do not affect the underlying disease process in the brain. Four drugs are currently available. Three of these (donepezil, rivastigmine and galantamine) increase the levels of a chemical in the brain called acetylcholine which is important in memory and thinking processes and they are used in mild to moderate AD. A fourth, memantine, acts on another chemical (glutamate) that is also important as a transmitter between nerve cells in the brain and is for moderate to severe AD.
In the absence of curative treatments, the goals of drug treatment are to improve or slow down loss in memory and thinking processes so as to maintain independent function, PF-05212377 (SAM-760) is a new drug which blocks another important chemical in the brain (serotonin or 5-hydroxytryptamine (5-HT)) at the type 6 receptors in the brain where this chemical acts. It has been developed for the symptomatic treatment of people with mild to moderate AD and is especially likely to be of benefit to patients who are already receiving a drug such as donepezil. There is also some preliminary evidence that it will be of particular value in people with AD who are also showing some disturbances in behaviour.
This study is an 18 week, placebo controlled study to evaluate the safety and effectiveness of PF-05212377 in patients with mild to moderate AD who also have some changes in behaviour and are taking stable doses of donepezil. Around 342 subjects will be recruited into this study and randomised to receive either the new drug or placebo.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1082
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion