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Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02585934
First Posted: October 26, 2015
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axovant Sciences Ltd.
  Purpose
This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.

Condition Intervention Phase
Alzheimer's Disease Drug: RVT-101 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:
  • Change from baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 items (ADAS-Cog-11) [ Time Frame: 24 weeks ]
  • Change from baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change - plus carer interview (CIBIC+) [ Time Frame: 24 weeks ]
  • Change in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Baseline and Week 24 ]
  • Change in EQ-5D Visual Analogue Scale (EQ-5D-VAS) [ Time Frame: Baseline and 24 weeks ]
  • Occurrence of all reported adverse events (AEs) and events noted by investigators on clinical examination, electrocardiograms (ECGs), routine laboratory assessments [ Time Frame: Baseline to 24 weeks or Early Termination ]

Enrollment: 1315
Actual Study Start Date: October 2015
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RVT-101
RVT-101 adjunct to 5 mg or 10 mg donepezil
Drug: RVT-101
once daily, oral, 35 mg tablets
Placebo Comparator: Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
Drug: Placebo
once daily, oral, pill manufactured to match RVT-101 35 mg tablet

Detailed Description:
This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject with AD
  • Ongoing donepezil therapy for AD
  • An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline
  • Hachinski Ischaemia score less than or equal to 4 at Screening.
  • If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
  • Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.
  • Subject has a reliable caregiver who is willing to report on subject's status throughout the study.

Exclusion Criteria:

Other Causes for Dementia

  • Diagnosis of vascular dementia
  • Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.

Confounding Medical Conditions

  • History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;
  • Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585934


  Show 197 Study Locations
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Vice President, Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02585934     History of Changes
Other Study ID Numbers: RVT-101-3001
First Submitted: October 22, 2015
First Posted: October 26, 2015
Last Update Posted: September 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Axovant Sciences Ltd.:
Alzheimer's disease
RVT-101
donepezil
intepirdine
dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents