CompletedPhase 3Results posted

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

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

Lead sponsor

Axovant Sciences Ltd.

Asset

Intepirdine

Listed sites

197

Recruiting sites

Enrollment

1,315

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 12-24•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•ADCS-Activities of Daily Living (ADCS-ADL)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02585934

Org study IDRVT-101-3001

Timeline

Milestones

Study start2015-10actual (month precision)

Study first posted2015-10-26estimated

Primary completion2017-09actual (month precision)

Study completion2017-09actual (month precision)

Last update posted2018-12-05actual

Results first posted2018-12-05actual

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

4 endpoints

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=584 Participants	0.39	0.211
Placebon=577 Participants	0.75	0.213

least square mean difference-0.3695% CI-0.95 - 0.22p0.2249Mixed Models Analysis

Secondary/protocol endpoint

ADAS-Cog-13 Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADAS-Cog

change from baseline, improvement

Secondary/registry result

ADAS-Cog-13 Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=583 Participants	0.26	0.233
Placebon=576 Participants	0.64	0.236

least square mean difference-0.3895% CI-1.03 - 0.27p0.2472Mixed Models Analysis

Function / daily living

2 endpoints

Primary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/registry result

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=588 Participants	-1.06	0.289
Placebon=575 Participants	-0.97	0.293

least square mean difference-0.0995% CI-0.90 - 0.72p0.8260Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=583 Participants	-0.08	0.339
Placebon=570 Participants	0.06	0.344

least square mean difference-0.1495% CI-1.09 - 0.80p0.7650Mixed Models Analysis

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24

Time frame:24 weeks

descriptive

Secondary/registry result

Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24

Time frame:24 weeks

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=577 Participants	4.18	0.037
Placebon=568 Participants	4.30	0.037

least square mean difference-0.1295% CI-0.22 - -0.02p0.0234Mixed Models Analysis

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

The Dependence Scale (DS) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma

Time frame:Week 6, Week 12, Week 18, Week 24

concentration, descriptive

Secondary/registry result/low confidence

The Dependence Scale (DS) Score Change From Baseline to Week 24

Time frame:Baseline, 24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
RVT-101n=580 Participants	0.30	0.070
Placebon=568 Participants	0.17	0.071

least square mean difference0.1295% CI-0.07 - 0.32p0.2096Mixed Models Analysis

Secondary/registry result/low confidence

Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma

Time frame:Week 6, Week 12, Week 18, Week 24

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	Reported bounds
RVT-101Summary Statistics at Week 6n=563 Participants	201.11	-191.88 - 210.78
Summary Statistics at Week 12n=579 Participants	170.95	-164.40 - 177.76
Summary Statistics at Week 18n=454 Participants	198.69	-189.36 - 208.48
Summary Statistics at Week 24n=562 Participants	193.36	-184.60 - 202.53

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.