Parkinson's DiseaseCogSMART-PDNCT03335150

Cognitive Rehabilitation for PD

A study testing CogSMART-PD and Supportive Care in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: CogSMART-PD and Supportive Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2015to 31 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Parkinson's disease
Mild Cognitive Impairment
Over 40 years of age
Fluent English speaker

Who cannot join

Other neurological conditions (e.g., stroke) besides Parkinson's disease

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161

Other trials in United States

About this study

Official title: Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Read the detailed description

Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

Conditions: Parkinson's Disease
Being tested: CogSMART-PD, Supportive Care
Keywords: Parkinson's disease, Rehabilitation, Cognition
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CogSMART-PDBehavioural
Cognitive Rehabilitation for persons with PD-MCI
Supportive CareBehavioural
Support Group for persons with PD-MCI

Study groups in NCT03335150
Study group	Role	What they receive
Supportive Care	Active comparator	Support Group for PD-MCI Receives: Behavioral: Supportive Care
CogSMART-PD	Experimental	Cognitive Rehabilitation for PD-MCI Receives: Behavioral: CogSMART-PD

What is being measured

The primary outcome is the main question the study is designed to answer.

Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
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.
Measured: Baseline and Week 10

Secondary outcomes (8)

Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
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.
Measured: Baseline and Week 10
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
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.
Measured: Baseline and Week 10
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
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.
Measured: Baseline and Week 10
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
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.
Measured: Baseline and Week 10
Memory for Intention Test (MIST) Total Score
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.
Measured: Baseline and Week 10
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
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.
Measured: Baseline and Week 10
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
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.
Measured: Baseline and Week 10
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
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.
Measured: Baseline and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 201531 Jan 2021

First posted7 Nov 2017
Study start2 Nov 2015
Primary completion30 Apr 2019
Study completion31 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03335150
Sponsor's protocol ID: E1691-I
Acronym: CogSMART-PD
Status last verified: Feb 2021
First submitted: 18 Oct 2017
Last updated: 23 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI
ClinicalTrials.gov ID: NCT03335150
Acronym / sponsor ID: CogSMART-PD / E1691-I
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, Rehabilitation, Cognition
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 2 Nov 2015 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 31 Jan 2021 (actual)
First posted: 7 Nov 2017 (actual)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Supportive Care	Active comparator	Behavioral: Supportive CareSupport Group for PD-MCI
CogSMART-PD	Experimental	Behavioral: CogSMART-PDCognitive Rehabilitation for PD-MCI

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of Parkinson's disease
Mild Cognitive Impairment
Over 40 years of age
Fluent English speaker

Key exclusion criteria (1 listed)

Other neurological conditions (e.g., stroke) besides Parkinson's disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CogSMART-PDCognitive Rehabilitation for persons with PD-MCI	Behavioural	CogSMART-PD
Supportive CareSupport Group for persons with PD-MCI	Behavioural	Supportive Care

Primary outcome

Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
Time frame: Baseline and Week 10
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.

8 secondary outcomes

Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
Time frame: Baseline and Week 10
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
Time frame: Baseline and Week 10
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
Time frame: Baseline and Week 10
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
Time frame: Baseline and Week 10
Memory for Intention Test (MIST) Total Score
Time frame: Baseline and Week 10
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
Time frame: Baseline and Week 10
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
Time frame: Baseline and Week 10
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
Time frame: Baseline and Week 10

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supportive Care	55	45
CogSMART-PD	55	50

Primary outcome: Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score

Time frame: Baseline and Week 10. Mean (Standard Deviation). Unit: score on a scale

Measure	Supportive Care n = 45	CogSMART-PD n = 50
Value	0.22 (2.35)	0.42 (2.43)

Supportive Care vs CogSMART-PD: Mean Difference (Final Values): 0.4856, p = 0.6662, Mixed Models Analysis
Supportive Care vs CogSMART-PD: Mean Difference (Final Values): 0.2415, p = 0.1617, Mixed Models Analysis
Supportive Care vs CogSMART-PD: Mean Difference (Final Values): 0.5087, p = 0.6236, Mixed Models Analysis

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supportive Care	0 of 55 (0%)	0 of 55 (0%)	0 of 55
CogSMART-PD	1 of 55 (1.8%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
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Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 1/2
Repurposing Lithium for Parkinson's Disease: a RCT
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Non-small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dawn M. Schiehser, PhD principal investigator

VA San Diego Healthcare System, San Diego, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CogSMART-PD and Supportive Care in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score (time frame: Baseline and Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03335150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.