CompletedPhase 2Results posted

Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

Lead sponsor

Axovant Sciences Ltd.

Asset

Intepirdine

Listed sites

Recruiting sites

Enrollment

484

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 14-26•Study partner/caregiver required

Primary endpoint

•Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change

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 IDNCT02669433

Org study IDRVT-101-2001

Timeline

Milestones

Study start2016-01actual (month precision)

Study first posted2016-02-01estimated

Primary completion2017-12actual (month precision)

Study completion2017-12actual (month precision)

Last update posted2019-04-26actual

Results first posted2019-04-26actual

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subject with probable DLB

•Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline

•Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator

•Patient has a reliable caregiver who is willing to report on the subject's status throughout the study

•Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion criteria

•Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.

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

Endpoints (6)

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

Caregiver / quality of life

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

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

Time frame:Change from Baseline at 24 weeks

ADAS-Cog

change from baseline, improvement

Secondary/registry result

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

Time frame:Change from Baseline at 24 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=73 Participants	1.68	0.774
RVT-101 35 mgn=73 Participants	2.15	0.769
RVT-101 70 mgn=71 Participants	1.01	0.796

Mean Difference (Final Values)-0.4795% CI-2.55 - 1.60p0.6531Mixed Models Analysis

Mean Difference (Final Values)0.6795% CI-1.41 - 2.75p0.5274Mixed Models Analysis

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24

Time frame:Change from Baseline at 24 weeks

change from baseline, improvement

Secondary/registry result

Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24

Time frame:Change from Baseline at 24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=75 Participants	4.42	0.127
RVT-101 35 mgn=74 Participants	4.27	0.128
RVT-101 70 mgn=72 Participants	4.35	0.131

Mean Difference (Final Values)0.1595% CI-0.2 - 0.5p0.3953Mixed Models Analysis

Mean Difference (Final Values)0.0795% CI-0.28 - 0.42p0.7008Mixed Models Analysis

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24

Time frame:Change from Baseline at 24 weeks

change from baseline, improvement

Primary/registry result/low confidence

Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24

Time frame:Change from Baseline at 24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=72 Participants	-0.55	1.039
RVT-101 35 mgn=72 Participants	1.45	1.025
RVT-101 70 mgn=69 Participants	-1.29	1.056

Mean Difference (Final Values)-2.0195% CI-4.80 - 0.79p0.158Mixed Models Analysis

Mean Difference (Final Values)0.7495% CI-2.08 - 3.55p0.6069Mixed 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.