Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
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| ClinicalTrials.gov Identifier: NCT02910102 |
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Recruitment Status :
Completed
First Posted : September 21, 2016
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease Dementia With Lewy Bodies Parkinson's Disease Dementia | Drug: RVT-101 35 mg Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 38 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | October 2016 |
| Actual Primary Completion Date : | November 2017 |
| Actual Study Completion Date : | November 2017 |
| Arm | Intervention/treatment |
|---|---|
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Sequence AB
RVT-101 35 mg in Period II and Placebo in Period IV
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Drug: RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets Drug: Placebo Placebo once daily, oral |
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Sequence BA
Placebo in Period II and RVT-101 35 mg in Period IV
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Drug: RVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets Drug: Placebo Placebo once daily, oral |
- 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 ]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
- 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) 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.
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| Ages Eligible for Study: | 50 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910102
| United States, Arizona | |
| US101 | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| US118 | |
| Simi Valley, California, United States, 93065 | |
| US117 | |
| Temecula, California, United States, 92591 | |
| United States, Florida | |
| US115 | |
| Boca Raton, Florida, United States, 33431 | |
| US109 | |
| Hallandale Beach, Florida, United States, 33009 | |
| US116 | |
| Miami, Florida, United States, 33137 | |
| US108 | |
| Pensacola, Florida, United States, 32502 | |
| United States, Georgia | |
| US106 | |
| Columbus, Georgia, United States, 31909 | |
| United States, Indiana | |
| US107 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| US102 | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Ohio | |
| US111 | |
| Columbus, Ohio, United States, 43210 | |
| Study Chair: | Ilise Lombardo, MD | Axovant Sciences, Inc., Senior VP Clinical Research |
Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
| Responsible Party: | Axovant Sciences Ltd. |
| ClinicalTrials.gov Identifier: | NCT02910102 |
| Other Study ID Numbers: |
RVT-101-2003 |
| First Posted: | September 21, 2016 Key Record Dates |
| Results First Posted: | April 28, 2020 |
| Last Update Posted: | April 28, 2020 |
| Last Verified: | January 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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RVT-101 intepirdine Alzheimer's disease |
Dementia with Lewy bodies Lewy body dementia Parkinson's Disease Dementia |
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Parkinson Disease Alzheimer Disease Dementia Lewy Body Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Tauopathies Neurocognitive Disorders Mental Disorders |