The MINDSET Study, sponsored by Axovant Sciences Ltd., is a new study looking at whether an innovatory new drug could be used to help improve the everyday lives of mild-to-moderate Alzheimer’s patients.
The purpose of this study is to understand whether an investigational drug known as ‘RVT 101’ improves Alzheimer’s patients’ cognition and ability to perform daily living activities when taken together with another drug called ‘donepezil’ (sometimes known as Aricept®).
What does it involve for the participant?
Participants will attend a total of 9 study visits over a 33-week period to assess their health and to study the effects of taking the drug. All participants will receive study-provided donepezil at no cost to them. Patients will then have a 50-50 chance of receiving either a RVT-101 tablet or a placebo tablet. All participants who complete the study will be eligible to continue into a 12-month extension study in which all participants will receive RVT-101.
How long is the study for? / Is it a one-off visit?
The study consists of 9 separate visits over a 33 week period. Participants who complete the study will have the opportunity to enroll in a 12-month extension study.
What do you hope the outcomes of the study will be?
In a previous 684-patient clinical study, the combination of RVT-101 and donepezil provided mild-to-moderate Alzheimer’s disease patients with statistically significant benefits on measures of cognition and ability to perform daily living activities, when compared to donepezil alone. It is hoped that this study will confirm these results and could be the final study required before regulators consider RVT-101 for approval.
Where is the study based?
The study is taking place at a number of sites across the UK. Log into your Join Dementia Research account to see if you are eligible. Transportation to and from study visits can be provided or reimbursed, and compensation for study-related time may also be available.