Phase 3 study of RVT-101 versus placebo in AD patients. V1.0
Research type
Research Study
Full title
A Phase 3, double-blind, randomized study of RVT-101 versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer's disease.
IRAS ID
192332
Contact name
Christopher Kipps
Contact email
Sponsor organisation
Axovant Sciences Ltd.
Eudract number
2015-002957-37
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a phase 3, double-blind, randomized study of RVT101 versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer’s disease.
Alzheimer’s disease is a progressive neurodegenerative disorder characterized by deterioration of memory and other aspects of cognition, progressive impairment of activities of daily living, and a variety of behavioral disturbances.
The purpose of this clinical study is to investigate how well RVT 101 works to improve cognitive function and ability to perform activities of daily living.
The drug under study is named RVT101. RVT101 is an “investigational” drug which has not been approved by the U.S. Food and Drug Administration, or any other health authority.
Previous studies have shown when RVT101 is taken in combination with the approved medication donepezil it may help cognition and performance of activities of daily living in patients with Alzheimer’s disease. Therefore, RVT101 is being tested in this large study to confirm the findings of the earlier studies.
Patients participating in this study will be randomly assigned to one of two treatment groups: RVT 101 or placebo (a study drug look alike that does not contain any active study drug ingredients). The results in these two groups will be compared to see if one treatment is better than the other. All patients will receive placebo at some point during the study, but they will not know at which point in the study this will occur to them. All participants will also be asked to continue to take donepezil at their current dose throughout the study.Approximately 1150 randomized subjects worldwide in 185 centers will take part in the study. Study participation will be for 33 weeks. Trial procedures include physical examination, routine blood tests, pregnancy testing, administration of rating scales, CT or MRI scan of subject’s brain and ECG.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0714
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion