Alzheimer's Disease, Dementia With Lewy Bodies, Parkinson's Disease Dementia
Conditions
Keywords
RVT-101, intepirdine, Alzheimer's disease, Dementia with Lewy bodies, Lewy body dementia, Parkinson's Disease Dementia
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.
Interventions
DRUGRVT-101 35 mg
RVT-101 once daily, oral, 35-mg tablets
DRUGPlacebo
Placebo once daily, oral
Sponsors
Axovant Sciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
68 participants signed consent and were screened for participation. Of these, 40 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. Subjects were allowed to re-screen if they failed the initial screening assessments. All subjects deemed eligible following run-in were randomized to a treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1: AB RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II
Placebo in Period IV | 21 |
| Sequence 2: BA Placebo: once daily, oral, matching tablets in Period II
RVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV | 17 |
| Total | 38 |
Baseline characteristics
| Characteristic | Sequence 1: AB | Sequence 2: BA | Total |
|---|---|---|---|
| Age, Continuous | 76.0 years | 73.8 years | 75.0 years |
| BMI | 27.312 kg/m^2 | 25.898 kg/m^2 | 26.680 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 11 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Female | 14 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 68 | 0 / 40 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 | 0 / 68 | 0 / 40 | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 68 | 0 / 40 | 0 / 38 | 0 / 38 |
Outcome results
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.
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
Time frame: Baseline, 2 weeks
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RVT-101 35 mg | 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 cm/sec | Standard Error 1.845 |
| Placebo | 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. | 1.47 cm/sec | Standard Error 1.874 |
p-value: 0.356595% CI: [-6.04, 2.23]Mixed Models Analysis
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.
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.
Time frame: Baseline, 2 weeks
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| RVT-101 35 mg | 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 cm/sec | Standard Error 1.517 |
| Placebo | 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. | 1.63 cm/sec | Standard Error 1.518 |
p-value: 0.92295% CI: [-3.73, 3.38]Mixed Models Analysis