Phase 2
N=269
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Dementia With Lewy Bodies
Bottom Line
View on ClinicalTrials.gov: NCT02669433 ↗Enrolled (actual)
269
Serious AEs
13.1%
Results posted
Apr 2019
Primary outcome: Primary: Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 — -0.55; 1.45; -1.29 units on a scale — p=0.158
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RVT-101 35 mg (Drug); RVT-101 70 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Axovant Sciences Ltd.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 |
-0.55; 1.45; -1.29 | 0.158 |
| SECONDARY Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24 |
1.68; 2.15; 1.01 | 0.6531 |
| SECONDARY Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24 |
4.42; 4.27; 4.35 | 0.3953 |
Summary
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02669433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.