Clinical trial NCT01646333: A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
Official title: A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: Parkinson Disease
Mild Cognitive Impairment
Cognition
Executive Function
Learning
Memory
Problem Solving
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2012-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks
timeFrame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks
Secondary outcomes:
measure: Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks
timeFrame: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks
Other outcomes:
measure: California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 6 Months
timeFrame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 6 months
measure: Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 6 Months
timeFrame: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months
Locations:
city: Richmond
country: United States
facility: VCU Parkinson's and Movement Disorders Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sarah K Lageman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: James P Bennett, Jr., M.D., Ph.D.
role: STUDY_CHAIR
References: