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

Axovant Sciences

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: RVT-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02585934

RVT-101-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,315 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,315 participants in 2 patient groups, including a placebo group

RVT-101

Experimental group

Description:

RVT-101 adjunct to 5 mg or 10 mg donepezil

Treatment:

Drug: RVT-101

Placebo

Placebo Comparator group

Description:

Placebo adjunct to 5 mg or 10 mg donepezil

Treatment:

Drug: Placebo