Trial Outcomes & Findings for Cognitive Rehabilitation for PD (NCT NCT03335150)
NCT ID: NCT03335150
Last Updated: 2021-02-23
Results Overview
The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.
COMPLETED
NA
110 participants
Baseline and Week 10
2021-02-23
Participant Flow
Participant milestones
| Measure |
Supportive Care
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
Enrolled + Assigned Group
|
54
|
55
|
|
Overall Study
PRE Testing Session
|
53
|
55
|
|
Overall Study
Commenced Group
|
47
|
52
|
|
Overall Study
POST Testing Session
|
45
|
50
|
|
Overall Study
COMPLETED
|
45
|
50
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Supportive Care
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information.
Baseline characteristics by cohort
| Measure |
Supportive Care
n=54 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=55 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.59 years
STANDARD_DEVIATION 7.06 • n=54 Participants
|
68.22 years
STANDARD_DEVIATION 7.98 • n=55 Participants
|
69.39 years
STANDARD_DEVIATION 7.60 • n=109 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=54 Participants
|
12 Participants
n=55 Participants
|
32 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=54 Participants
|
43 Participants
n=55 Participants
|
77 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=54 Participants
|
3 Participants
n=55 Participants
|
7 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=54 Participants
|
52 Participants
n=55 Participants
|
102 Participants
n=109 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=54 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=54 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=54 Participants
|
2 Participants
n=55 Participants
|
3 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
2 Participants
n=54 Participants
|
3 Participants
n=55 Participants
|
5 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=54 Participants
|
1 Participants
n=55 Participants
|
2 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Race · White or Caucasian
|
49 Participants
n=54 Participants
|
49 Participants
n=55 Participants
|
98 Participants
n=109 Participants
|
|
Education
|
16.15 years
STANDARD_DEVIATION 2.41 • n=54 Participants
|
15.8 years
STANDARD_DEVIATION 2.29 • n=55 Participants
|
15.97 years
STANDARD_DEVIATION 2.34 • n=109 Participants
|
|
Duration of Disease
|
69.02 months
STANDARD_DEVIATION 55.97 • n=53 Participants • 54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information.
|
73.27 months
STANDARD_DEVIATION 45.43 • n=55 Participants • 54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information.
|
71.18 months
STANDARD_DEVIATION 50.68 • n=108 Participants • 54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information.
|
|
Cognitive Status
Normal Cognition
|
14 Participants
n=54 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
9 Participants
n=54 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
23 Participants
n=108 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
|
Cognitive Status
Mild Cognitive Impairment
|
40 Participants
n=54 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
45 Participants
n=54 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
85 Participants
n=108 Participants • 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.
|
|
Motor Symptoms
|
12.28 seconds
STANDARD_DEVIATION 4.85 • n=51 Participants • 54 subjects were enrolled into the Supportive Care Group; however, 1 subject dropped before their baseline assessment, and 2 were unable to complete the measure in session. 55 subjects were enrolled into the CogSMART-PD group; however, 1 subject was unable to complete the measure in session.
|
11.76 seconds
STANDARD_DEVIATION 3.73 • n=54 Participants • 54 subjects were enrolled into the Supportive Care Group; however, 1 subject dropped before their baseline assessment, and 2 were unable to complete the measure in session. 55 subjects were enrolled into the CogSMART-PD group; however, 1 subject was unable to complete the measure in session.
|
12.01 seconds
STANDARD_DEVIATION 4.30 • n=105 Participants • 54 subjects were enrolled into the Supportive Care Group; however, 1 subject dropped before their baseline assessment, and 2 were unable to complete the measure in session. 55 subjects were enrolled into the CogSMART-PD group; however, 1 subject was unable to complete the measure in session.
|
|
Baseline Medication
|
685.26 milligrams
STANDARD_DEVIATION 445.71 • n=53 Participants • 54 subjects enrolled in the Supportive Care group; however, 1 subject's medication info was missing. 55 subjects enrolled in the CogSMART-PD group; however, 1 subject dropped before their baseline assessment.
|
764.17 milligrams
STANDARD_DEVIATION 483.10 • n=54 Participants • 54 subjects enrolled in the Supportive Care group; however, 1 subject's medication info was missing. 55 subjects enrolled in the CogSMART-PD group; however, 1 subject dropped before their baseline assessment.
|
725.09 milligrams
STANDARD_DEVIATION 464.46 • n=107 Participants • 54 subjects enrolled in the Supportive Care group; however, 1 subject's medication info was missing. 55 subjects enrolled in the CogSMART-PD group; however, 1 subject dropped before their baseline assessment.
|
PRIMARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.
The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=50 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
|
0.22 score on a scale
Standard Deviation 2.35
|
0.42 score on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.
D-KEFS: 20 Questions Test measures executive function. The range of scores is 1 - 19 with a higher score representing better executive function. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=50 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
|
-0.09 score on a scale
Standard Deviation 2.70
|
1.06 score on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.
The measure examines self-reported change in cognition over time. Scores range from 16 - 80, with higher scores indicating worse functioning (or more cognitive decline). Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=49 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
|
-5.51 score on a scale
Standard Deviation 7.84
|
-8.86 score on a scale
Standard Deviation 8.19
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 2 were missing info. Therefore, 48 completed measure.
CPSA measures cognitive problems and memory strategy use. The range for scores is 0 - 90, with higher scores indicating higher frequency of using memory and thinking strategies. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=48 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
|
-0.24 score on a scale
Standard Deviation 11.16
|
10.17 score on a scale
Standard Deviation 16.96
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 1 was missing info. 39 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 2 were missing info, and 4 declined a caregiver. 44 completed measure.
IQCODE is a self-report questionnaire for caregivers that measures possible dementia and cognitive decline of the patient. The range for scores is 26 - 130, with higher score representing worse functioning/higher cognitive decline in the patient. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=39 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=44 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
|
-4.49 score on a scale
Standard Deviation 7.03
|
-10.46 score on a scale
Standard Deviation 12.55
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.
MIST measures prospective memory. The range for scores is 0 - 48 with a higher score representing better prospective memory. Scores reported below are change score.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=50 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Memory for Intention Test (MIST) Total Score
|
4 score on a scale
Standard Deviation 5.43
|
2.82 score on a scale
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.
WHOQOL-BREF is a self-reported measure of quality of life. Transformed score for the psychological domain ranges from 0 to 100. Higher scores indicate better quality of life. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=49 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
|
4.02 score on a scale
Standard Deviation 11.60
|
0.04 score on a scale
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.
The PDQ-39 is a patient-reported measure of health and quality life over a 1-month period in individuals with Parkinson's disease. Total scores range from 0 to 156. Higher scores indicate poorer quality of life. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=45 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=49 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
|
-2.31 score on a scale
Standard Deviation 11.56
|
-2.69 score on a scale
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 2 were missing info. 38 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 3 were missing info, and 4 declined a caregiver. 43 completed measure.
The NPI-Q is a self-reported measure of neuropsychiatric symptoms over a 1 month period and 1 year period. Total month scores range from 0 to 156. Higher scores indicate greater severity of neuropsychiatric symptoms. Scores reported below are change scores.
Outcome measures
| Measure |
Supportive Care
n=38 Participants
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=43 Participants
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
|
1.82 score on a scale
Standard Deviation 6.63
|
-2.30 score on a scale
Standard Deviation 9.15
|
Adverse Events
Supportive Care
CogSMART-PD
Serious adverse events
| Measure |
Supportive Care
n=55 participants at risk
Support Group for PD
Supportive Care: Support Group for persons with PD
|
CogSMART-PD
n=55 participants at risk
Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD
|
|---|---|---|
|
Surgical and medical procedures
Clinical Motor Exam
|
0.00%
0/55 • 3 years
|
1.8%
1/55 • Number of events 1 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place