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Completed

NCT Number: NCT03335150

Cognitive Rehabilitation for PD

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CogSMART-PD

Behavioral

Cognitive Rehabilitation for persons with PD-MCI

Supportive Care

Behavioral

Support Group for persons with PD-MCI

Primary outcomes

  1. 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.

Secondary outcomes

  1. Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score

    Time frame: Baseline and Week 10

    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.

  2. Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score

    Time frame: Baseline and Week 10

    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.

  3. Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score

    Time frame: Baseline and Week 10

    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.

  4. Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score

    Time frame: Baseline and Week 10

    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.

  5. Memory for Intention Test (MIST) Total Score

    Time frame: Baseline and Week 10

    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.

  6. World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score

    Time frame: Baseline and Week 10

    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.

  7. Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score

    Time frame: Baseline and Week 10

    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.

  8. Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score

    Time frame: Baseline and Week 10

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

Acronym: CogSMART-PD

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Nov 7, 2017
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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