Trial Outcomes & Findings for Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia (NCT NCT02910102)

Last Updated: 2020-04-28

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline, 2 weeks

Results posted on

2020-04-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Sequence 1: AB RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II Placebo in Period IV	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
Overall Study STARTED	21	17
Overall Study Safety Population	21	17
Overall Study Intent to Treat (ITT) Population	21	17
Overall Study Per-Protocol Population	20	17
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1: AB n=21 Participants RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II Placebo in Period IV	Sequence 2: BA n=17 Participants Placebo: once daily, oral, matching tablets in Period II RVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV	Total n=38 Participants Total of all reporting groups
Age, Continuous	76.0 years n=5 Participants	73.8 years n=7 Participants	75.0 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	27.312 kg/m^2 n=5 Participants	25.898 kg/m^2 n=7 Participants	26.680 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks

Population: ITT Population

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

Outcome measures

Outcome measures
Measure	RVT-101 35 mg n=36 Participants Subjects who dosed with RVT-101 in both sequences (AB and BA) are included in this analysis	Placebo n=37 Participants Subjects who dosed with Placebo in both sequences (AB and BA) are included in this analysis
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	1.47 cm/sec Standard Error 1.874

PRIMARY outcome

Timeframe: Baseline, 2 weeks

Population: ITT Population

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.