Mild Cognitive Impairment, Parkinson's Disease
Conditions
Keywords
Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving
Brief summary
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings. Results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Detailed description
The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.
Interventions
BEHAVIORALMemory and Problem-Solving Intervention
8 weekly 1 hour sessions of memory compensation and problem-solving strategies
BEHAVIORALSupportive Therapy
8 weekly 1 hour sessions of non-directive supportive therapy.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Parkinson's Disease * Clinical diagnosis of Mild Cognitive Impairment
Exclusion criteria
* Clinical diagnosis of Dementia * Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks | Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks | Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks | Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks | Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 6 Months | Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 6 months | Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 6 months |
| Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 6 Months | Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months | Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 6 months |
Countries
United States
Outcome results
None listed