Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Alzheimer's Disease · Dementia With Lewy Bodies · Parkinson's Disease Dementia
Bottom Line
View on ClinicalTrials.gov: NCT02910102 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RVT-101 35 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Axovant Sciences Ltd.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-0.43; 1.47 | 0.3565 |
| PRIMARY 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. |
1.46; 1.63 | 0.9220 |
Summary
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02910102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.