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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02910102
• Date of registration: 16/09/2016
• Prospective Registration: Yes
• Primary sponsor: Axovant Sciences Ltd.
• Public title: Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
• Scientific title: 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
• Date of first enrolment: October 2016
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02910102
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ilise Lombardo, MD
• Affiliation: Axovant Sciences, Inc., Senior VP Clinical Research

Key inclusion & 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.



Age minimum: 50 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease Dementia

Dementia With Lewy Bodies

Alzheimer's Disease

Intervention(s)

Drug: Placebo

Drug: RVT-101 35 mg

Primary Outcome(s)

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. [Time Frame: Baseline, 2 weeks]

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. [Time Frame: Baseline, 2 weeks]

Secondary ID(s)

RVT-101-2003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02910102