← Trials/Trial dossier/NCT02586909

TerminatedPhase 3Results posted

12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

Lead sponsor

Axovant Sciences Ltd.

Asset

Intepirdine

Listed sites

169

Recruiting sites

Enrollment

1,099

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-86

Primary endpoint

•Occurrence of Adverse Events (AEs)

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 IDNCT02586909

Org study IDRVT-101-3002

Timeline

Milestones

Study first posted2015-10-27estimated

Study start2016-04-26actual

Primary completion2018-03-12actual

Study completion2018-03-12actual

Last update posted2020-04-17actual

Results first posted2020-04-17actual

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age86 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Completed last on-treatment visit of the lead-in study RVT-101-3001

Exclusion criteria

•Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments

Time frame:Baseline to 12 months or Early Termination

event count, event

Primary/registry result

Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments

Time frame:Baseline to 12 months or Early Termination

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RVT-101 35 mg TabletsSubjects with at least one on-treatment AEn=1099 Participants	549	-
Subjects with no on-Treatment AEn=1099 Participants	550	-

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.