Objective: To describe the rationale and design of a Phase 2 study that evaluates the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer’s disease (AD), dementia with Lewy bodies (DLB), or Parkinson’s disease with dementia (PDD).

Background: Approximately 35-40% of community-dwelling healthy adults over age 65 fall each year (American Geriatrics Society et al 2001). Adults with dementia have an approximately eight-fold increased likelihood of experiencing a fall compared to controls (Allan et al 2009). Intepirdine is a 5HT6 antagonist in development for the treatment of AD and DLB. In a 48-week placebo-controlled study of 684 patients with mild-moderate AD on stable background donepezil therapy, intepirdine demonstrated statistically significant benefits in measurements of cognition and function. The adverse event profile of donepezil plus intepirdine was similar to that of donepezil alone. Intriguingly, the incidence of falls reported as an adverse event was approximately three-fold lower in the groups that received intepirdine versus the group that received placebo. To further investigate this observation, a Phase 2 study was designed to evaluate the effect of intepirdine on gait and balance functions associated with falls.

Methods: This is a Phase 2 multicenter placebo-controlled crossover study of approximately 40 subjects with AD, DLB, or PDD who are on stable cholinesterase inhibitor therapy. Subjects are randomized to one of two treatment sequences:

– Intepirdine during the early treatment period and placebo during the late treatment period
– Placebo during the early treatment period and intepirdine during the late treatment period

The primary objective is to evaluate intepirdine’s effect on quantitative gait measurements using computerized assessment tools. Secondary objectives include the evaluation of intepirdine’s effect on qualitative and clinical gait and balance assessments.

Results: Results are expected in 2017.

Conclusions: Intepirdine is a 5HT6 antagonist in development for the treatment of dementia. This Phase 2 study aims to explore the reasons for the three-fold lower incidence of falls observed with intepirdine treatment in
a prior 684-patient study in mild-moderate AD. Intepirdine is also being evaluated in a 1,150 patient global Phase 3 study in AD and a 240 patient Phase 2b study in DLB, with results expected in 2017.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/rationale-and-design-of-a-phase-2-study-to-evaluate-the-efficacy-of-intepirdine-rvt-101-in-improving-gait-and-balance-in-patients-with-dementia/