Open-Label Extn Study, Safety & Tolerability RVT-101 in AD patients V1
Research type
Research Study
Full title
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s Disease
IRAS ID
204750
Contact name
Christopher Kipps
Contact email
Sponsor organisation
Axovant Sciences Limited
Eudract number
2016-000587-42
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
This is a long term open label extension study of the safety and tolerability of RVT-101 in subjects with 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 study will include subjects with Alzheimer's disease who have successfully completed the preceding lead in study and the study objective is to assess the long term safety and tolerability of RVT-101 at a dose of 35 mg daily in a real-world setting over a 12 month period.
The study will include approximately 1150 patients and 185 study centers worldwide. Participation will last for approximately 54 weeks comprising a 52 week treatment period and 2 week follow up period.
There may be an additional 4 week screening period for patients whose final treatment visit 8 in the lead in study does not serve as visit 1 for this extension study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0256
Date of REC Opinion
25 May 2016
REC opinion
Favourable Opinion