Trial Outcomes & Findings for Neurobiological Drivers of Mobility Resilience: The Dopaminergic System (NCT NCT04325503)

Last Updated: 2024-04-04

Results Overview

Average gait speed as measured using wearable sensors worn during walking tasks. Gait speed is measured in meters per second.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

7-13 days after beginning treatment.

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Carbidopa and Carbidopa-Levodopa Treatment All participants treated with 25 mg carbidopa three times daily (TID) and 1.5 pills of 25/100 mg carbidopa-levodopa TID for parkinsonian signs in older persons (standard dosing, frequency for a duration for 1-2 weeks).
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Carbidopa and Carbidopa-Levodopa Treatment All participants treated with 25 mg carbidopa three times daily (TID) and 1.5 pills of 25/100 mg carbidopa-levodopa TID for parkinsonian signs in older persons (standard dosing, frequency for a duration for 1-2 weeks).
Overall Study Withdrawal by Subject	1
Overall Study PI decided to remove them from trial as they lacked motor symptoms being studied.	2

Baseline Characteristics

Average gait speed was not collected for 3 participants because they withdrew (Two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints). Gait data was not collected for one participant due to software error.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=14 Participants carbidopa and carbidopa-levodopa treatment for parkinsonian signs in older persons using standard dosing, frequency for a duration for 1-2 weeks carbidopa: carbidopa and carbidopa-levodopa standard treatment
Age, Continuous	73 years STANDARD_DEVIATION 6.56 • n=14 Participants
Sex: Female, Male Female	6 Participants n=14 Participants
Sex: Female, Male Male	8 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants
Race (NIH/OMB) White	14 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Region of Enrollment United States	14 Participants n=14 Participants
Average Gait Speed	0.882 meters/second STANDARD_DEVIATION 0.072 • n=10 Participants • Average gait speed was not collected for 3 participants because they withdrew (Two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints). Gait data was not collected for one participant due to software error.
Montreal Cognitive Assessment (MoCA) Score	26.27 score on a scale STANDARD_DEVIATION 2.76 • n=11 Participants • MoCA was not collected for 3 participants because they withdrew from the study (two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints).
Mini Balance Evaluation Systems Test (Mini-BESTest)	20.09 score on a scale STANDARD_DEVIATION 4.253 • n=11 Participants • Mini-BESTest was not collected for 3 participants because they withdrew from the study (two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints).
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III total	29.93 units on a scale STANDARD_DEVIATION 11.672 • n=14 Participants
Short Activities-specific Balance Confidence (sABC) scale score	76.67 score on a scale n=10 Participants • sABC was not collected for 3 participants because they withdrew from the study (two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints). One participant did not complete questionnaire due to tech error.
Cognitive z-score	-0.151 Z-score STANDARD_DEVIATION 0.751 • n=10 Participants • Cognitive z-scores were not collected for 3 participants because they withdrew from the study (two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints). One participant did not complete all cognitive testing due to language barrier.
Wechsler Adult Intelligence Scale Digit Symbol Test Score	54.67 score on a scale STANDARD_DEVIATION 22.472 • n=9 Participants • The digit symbol test was not collected for 3 participants because they withdrew from the study (two participants were withdrawn from the study due to lack of motor symptoms. One participant withdrew from study due to personal time constraints). Two participants did not complete testing due to tech error.

PRIMARY outcome

Timeframe: 7-13 days after beginning treatment.

Population: Gait speed data was missing for one participant due to software error.

Average gait speed as measured using wearable sensors worn during walking tasks. Gait speed is measured in meters per second.