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

A

Axovant Sciences

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Drug: Placebo
Drug: RVT-101 35 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02910102
RVT-101-2003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

38 patients

Sex

All

Ages

50 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

38 participants in 2 patient groups

Sequence AB
Other group
Description:
RVT-101 35 mg in Period II and Placebo in Period IV
Treatment:
Drug: RVT-101 35 mg
Drug: Placebo
Sequence BA
Other group
Description:
Placebo in Period II and RVT-101 35 mg in Period IV
Treatment:
Drug: RVT-101 35 mg
Drug: Placebo

Trial documents
2

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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