Trial · NCT02669433

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

NCT02669433, Phase 2, Completed, Axovant Sciences Ltd.; results first posted 2019-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study. Trials, record NCT02669433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02669433

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
NCT number: NCT02669433
Status: Completed
Phases: Phase 2
Enrollment: 484 participants, actual
Lead sponsor: Axovant Sciences Ltd.
Conditions: Dementia With Lewy Bodies
Interventions: RVT-101 35 mg, RVT-101 70 mg, Placebo
First posted: 2016-02-01
Last updated: 2019-04-26
Results first posted: 2019-04-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	Change from Baseline at 24 weeks	The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
Secondary	Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	Change from Baseline at 24 weeks	The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Secondary	Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	Change from Baseline at 24 weeks	To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	Change from Baseline at 24 weeks	UPDRS Primary Population	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	Change from Baseline at 24 weeks	ITT Population	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	Change from Baseline at 24 weeks	ITT Population	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	Placebo	-0.55	Standard Error 1.039	units on a scale
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	RVT-101 35 mg	1.45	Standard Error 1.025	units on a scale
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	RVT-101 70 mg	-1.29	Standard Error 1.056	units on a scale
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	Placebo	1.68	Standard Error 0.774	units on a scale
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	RVT-101 35 mg	2.15	Standard Error 0.769	units on a scale
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	RVT-101 70 mg	1.01	Standard Error 0.796	units on a scale
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	Placebo	4.42	Standard Error 0.127	units on a scale
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	RVT-101 35 mg	4.27	Standard Error 0.128	units on a scale
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	RVT-101 70 mg	4.35	Standard Error 0.131	units on a scale

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	91
Overall Study	STARTED	RVT-101 35 mg	89
Overall Study	STARTED	RVT-101 70 mg	89
Overall Study	Safety Population	Placebo	91
Overall Study	Safety Population	RVT-101 35 mg	89
Overall Study	Safety Population	RVT-101 70 mg	88
Overall Study	Intent to Treat (ITT) Population	Placebo	89
Overall Study	Intent to Treat (ITT) Population	RVT-101 35 mg	89
Overall Study	Intent to Treat (ITT) Population	RVT-101 70 mg	87
Overall Study	Per-Protocol Population	Placebo	78

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events162

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fall	Injury, poisoning and procedural complications	Placebo	19	91
other	Fall	Injury, poisoning and procedural complications	RVT-101 35 mg	17	89
other	Fall	Injury, poisoning and procedural complications	RVT-101 70 mg	18	88
other	Urinary tract infection	Infections and infestations	Placebo	4	91
other	Urinary tract infection	Infections and infestations	RVT-101 35 mg	7	89
other	Urinary tract infection	Infections and infestations	RVT-101 70 mg	7	88
other	Constipation	Gastrointestinal disorders	Placebo	5	91
other	Constipation	Gastrointestinal disorders	RVT-101 35 mg	9	89
other	Constipation	Gastrointestinal disorders	RVT-101 70 mg	6	88
other	Orthostatic hypotension	Vascular disorders	Placebo	12	91

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	91
Total, all-cause mortality	RVT-101 35 mg	1	89
Total, all-cause mortality	RVT-101 70 mg	2	88
Total, other adverse events	Placebo	66	91
Total, other adverse events	RVT-101 35 mg	69	89
Total, other adverse events	RVT-101 70 mg	59	88
Total, serious adverse events	Placebo	11	91
Total, serious adverse events	RVT-101 35 mg	11	89
Total, serious adverse events	RVT-101 70 mg	13	88

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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