CompletedPhase 2Results posted

Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia

A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia

Lead sponsor

Axovant Sciences Ltd.

Asset

Intepirdine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, Lewy body dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 14-26

Primary endpoints

•Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind•Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End

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 IDNCT02910102

Org study IDRVT-101-2003

Timeline

Milestones

Study first posted2016-09-21estimated

Study start2016-10actual (month precision)

Primary completion2017-11actual (month precision)

Study completion2017-11actual (month precision)

Last update posted2020-04-28actual

Results first posted2020-04-28actual

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Alzheimer’s diseaseLewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements Subjects must be on stable background acetylcholinesterase inhibitor therapy

Exclusion criteria

History and/or evidence of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator) Any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Endpoints (4)

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.

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

Time frame:Baseline, 2 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

Time frame:Baseline, 2 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

Time frame:Baseline, 2 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm/sec	Standard error
RVT-101 35 mgn=36 Participants	-0.43	1.845
Placebon=37 Participants	1.47	1.874

Mean Difference (Final Values)-1.9095% CI-6.04 - 2.23p0.3565Mixed Models Analysis

Primary/registry result

Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.

Time frame:Baseline, 2 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm/sec	Standard error
RVT-101 35 mgn=36 Participants	1.46	1.517
Placebon=37 Participants	1.63	1.518

Mean Difference (Final Values)-0.1795% CI-3.73 - 3.38p0.9220Mixed Models Analysis

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.