Clinical trial NCT02910102: Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Dementia With Lewy Bodies
Parkinson's Disease Dementia
Keywords: RVT-101
intepirdine
Alzheimer's disease
Dementia with Lewy bodies
Lewy body dementia
Parkinson's Disease Dementia
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: 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.
timeFrame: Baseline, 2 weeks
measure: 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.
timeFrame: Baseline, 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US101
state: Arizona
city: Simi Valley
country: United States
facility: US118
state: California
city: Temecula
country: United States
facility: US117
state: California
city: Boca Raton
country: United States
facility: US115
state: Florida
city: Hallandale Beach
country: United States
facility: US109
state: Florida
city: Miami
country: United States
facility: US116
state: Florida
city: Pensacola
country: United States
facility: US108
state: Florida
city: Columbus
country: United States
facility: US106
state: Georgia
city: Indianapolis
country: United States
facility: US107
state: Indiana
city: Ann Arbor
country: United States
facility: US102
state: Michigan
city: Columbus
country: United States
facility: US111
state: Ohio
Study officials:
affiliation: Axovant Sciences, Inc., Senior VP Clinical Research
name: Ilise Lombardo, MD
role: STUDY_CHAIR
References: