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

Study Overview
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Brief Summary
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This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.

Detailed Description
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To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative gait and balance parameters. Each subject will be randomized 1:1 to one of the following sequences: Sequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late treatment period Sequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late treatment period Treatment A = RVT-101 35 mg once daily. Treatment B = Placebo once daily.

Official Title
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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

Conditions
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Alzheimer's Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia

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


Participation Criteria
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Eligibility Criteria
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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 Key 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence AB<br>RVT-101 35 mg in Period II and Placebo in Period IV | Drug: RVT-101 35 mg<br>* RVT-101 once daily, oral, 35-mg tablets<br>Drug: Placebo<br>* Placebo once daily, oral<br>|
| Other: Sequence BA<br>Placebo in Period II and RVT-101 35 mg in Period IV | Drug: RVT-101 35 mg<br>* RVT-101 once daily, oral, 35-mg tablets<br>Drug: Placebo<br>* Placebo once daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period | Baseline, 2 weeks | 
| 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. | Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period. | Baseline, 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RVT-101, intepirdine, Alzheimer's disease, Dementia with Lewy bodies, Lewy body dementia, Parkinson's Disease Dementia