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Trial Outcomes & Findings for Cognitive Training in Parkinson's Disease (NCT NCT05495997)

NCT ID: NCT05495997

Last Updated: 2025-08-11

Results Overview

Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2025-08-11

Participant Flow

Participant milestones

Participant milestones
Measure
Mental Imagery
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
Participants will receive psychoeducation on cognition and brain health.
Overall Study
STARTED
15
15
Overall Study
Completed 18 Week Follow up Cognitive Tests
15
13
Overall Study
Completed 18 Week Follow up fMRI
15
12
Overall Study
COMPLETED
15
13
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Training in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mental Imagery
n=15 Participants
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
n=15 Participants
Participants will receive psychoeducation on cognition and brain health.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
67.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
67.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
67.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
12 Participants
n=7 Participants
23 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=5 Participants
15 Participants
n=7 Participants
28 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
12 Participants
n=5 Participants
14 Participants
n=7 Participants
26 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 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
Region of Enrollment
United States
15 Participants
n=5 Participants
15 Participants
n=7 Participants
30 Participants
n=5 Participants
Years of Education
17.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
18.3 years
STANDARD_DEVIATION 1.8 • n=7 Participants
17.7 years
STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.

Outcome measures

Outcome measures
Measure
Mental Imagery
n=15 Participants
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
n=15 Participants
Participants will receive psychoeducation on cognition and brain health.
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
Baseline
49.9 T-score
Standard Deviation 7.2
49.1 T-score
Standard Deviation 8.4
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
6 weeks
50 T-score
Standard Deviation 7.2
45.9 T-score
Standard Deviation 5.1

PRIMARY outcome

Timeframe: 18 weeks

Population: 15 in the Mental Imagery and 13 in the Psychoeducation group completed 18-week assessments.

Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.

Outcome measures

Outcome measures
Measure
Mental Imagery
n=15 Participants
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
n=13 Participants
Participants will receive psychoeducation on cognition and brain health.
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
Baseline
49.9 T-score
Standard Deviation 7.2
49.1 T-score
Standard Deviation 8.4
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
18 weeks
49.4 T-score
Standard Deviation 7.4
46.9 T-score
Standard Deviation 6.1

SECONDARY outcome

Timeframe: 6 weeks

T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.

Outcome measures

Outcome measures
Measure
Mental Imagery
n=15 Participants
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
n=15 Participants
Participants will receive psychoeducation on cognition and brain health.
Change in Composite Executive Function T-scores at 6 Weeks
Baseline
53.1 T-score
Standard Deviation 7.9
48.7 T-score
Standard Deviation 7.4
Change in Composite Executive Function T-scores at 6 Weeks
6 weeks
54.7 T-score
Standard Deviation 8.2
51 T-score
Standard Deviation 9.5

SECONDARY outcome

Timeframe: 18 weeks

Population: 15 in the Mental Imagery group and 13 in the Psychoeducation group completed 18-week assessments

T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.

Outcome measures

Outcome measures
Measure
Mental Imagery
n=15 Participants
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
n=13 Participants
Participants will receive psychoeducation on cognition and brain health.
Change in Composite Executive Function T-scores at 18 Weeks
Baseline
53.1 T-score
Standard Deviation 7.9
48.7 T-score
Standard Deviation 7.4
Change in Composite Executive Function T-scores at 18 Weeks
18 weeks
55.1 T-score
Standard Deviation 9.6
49.5 T-score
Standard Deviation 7.8

Adverse Events

Mental Imagery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Psychoeducation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sule Tinaz

Yale School of Medicine

Phone: 203-737-6158

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place