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

Study Overview
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Brief Summary
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This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

Detailed Description
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The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies. The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo). Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

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

Conditions
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Dementia With Lewy Bodies

Intervention / Treatment
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* Drug: RVT-101 35 mg
* Drug: RVT-101 70 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVT-101 35 mg<br>RVT-101 35 mg once daily | Drug: RVT-101 35 mg<br>* once daily, oral, 35-mg tablets<br>|
| Experimental: RVT-101 70 mg<br>RVT-101 70 mg once daily | Drug: RVT-101 70 mg<br>* once daily, oral, 35-mg tablets<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* once daily, oral, matching tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 | 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. | Change from Baseline at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24 | 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. | Change from Baseline at 24 weeks | 
| Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24 | 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. | Change from Baseline at 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia with Lewy bodies, Lewy bodies, intepirdine, RVT-101, dementia