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MINDSET study

Clinical Trials Watch

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Study Information

Name of the study

Study evaluating RVT-101 in subjects with mild to moderate Alzheimer's disease on donepezil treatment: MINDSET Study

Study sponsor

Axovant Sciences Ltd.

Disease

Alzheimer’s disease (mild – moderate stages)

Information about the drug that will be tested in the study

Name of drug

The investigational medication is called RVT-101

Administration

  • Oral pill taken once daily.
  • Add-on therapy to donepezil (this means that the study drug has to be taken together with donepezil, an existing treatment for Alzheimer’s disease).

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected at random to either receive:

  • Donepezil + RVT-101 (the study drug)
  • Donepezil + Placebo (a dummy treatment).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

All participants will receive donepezil (an existing treatment for Alzheimer’s disease, donepezil is sometimes known as Aricept), at no cost, this will be provided by the study.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of this study is to investigate how effective RVT-101, in combination with donepezil (one of the existing treatments for Alzheimer’s disease) will be in helping with the person with dementia’s cognition and ability to perform daily living activities, as compared with donepezil alone

How long will the treatment last?

The study will last approximately 6 months.

All participants who complete the study will have the opportunity to participate in a one-year follow-on extension of the study, during which all patients will receive the study drug i.e. RVT-101.

What will your involvement entail?

Participants will be asked to:

  • Attend a study-screening visit to determine if the person can participate in the study.
  • Come to a study center for 9 study visits (including the study-screening visit) to assess health and/or study drug effects.
  • Take study-provided donepezil (the generic form of Aricept®) throughout the course of the study.
  • Take the investigational drug or placebo for approximately 6 months.
  • The study will also involve the participation of a carer (study partner) who will be asked questions about how the person with Alzheimer's is feeling and functioning.

Who can participate in this study?

Who can participate in the study?

To take part in the study, the person must:

  • Be 50 to 85 years old
  • Have a diagnosis of mild-to-moderate Alzheimer’s disease
  • Be taking the medication donepezil (sometimes known as Aricept)
  • Have a caregiver or loved one who is willing to oversee his/her involvement in the study, accompany him/her to the visits and provide information about how he/she is doing throughout the study.

Additional inclusion requirements may apply.

Who cannot participate in the study?

People cannot participate if they have

  • A diagnosis (or evidence) of dementia other than Alzheimer’s disease (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).
  • A significant psychiatric disorder (schizophrenia, bipolar affective disorder, etc.) that in the opinion of the researcher could affect his/her participation in the study.
  • Have any other relevant disease that in the opinion of the researcher could affect his/her participation in the study.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

The following European countries are expected to be involved in the study:

  • Czech Republic
  • France
  • Germany
  • Italy
  • Poland
  • Slovakia
  • Spain
  • United Kingdom

Estimated start date of recruitment

Spring 2016 for Europe

Completion date

Data is expected in 2017

Information for your doctor

EudraCT Number:

2015-002957-37

Clinicaltrials.gov identifier

NCT02585934

Study contact information

mindset@axovant.com

Study website

http://www.alzheimersglobalstudy.com/

Link to full text

https://clinicaltrials.gov/ct/show/NCT02585934

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website).

The pharmaceutical company running this trial (AXOVANT) has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 

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Last Updated: Wednesday 13 July 2016

 

 
 

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