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Clinical Trial Summary

Mild cognitive impairment is experienced by approximately 30% of patients with Parkinson's disease (PD-MCI), often affecting executive functions. There is currently no pharmacological treatment available for PD-MCI and non-pharmacological treatments are still scarce. The aim of this study was to test preliminary efficacy/effectiveness of two home-based cognitive interventions adapted for patients with PD-MCI: Goal Management Training, adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises. Twelve persons with PD-MCI with executive dysfunctions, as measured by extensive neuropsychological evaluation, were randomly assigned to one of two intervention groups. Both groups received five sessions each lasting 60-90 minutes for five weeks, in presence of the caregiver. Measures were collected at baseline, mid-point, at one-week, four-week and 12-week follow-ups. Primary outcomes were executive functions assessed by subjective (DEX questionnaire patient- and caregiver-rated) and objective (Zoo Map Test) measures. Secondary outcomes included quality of life (PDQ-39), global cognition (DRS-II), and neuropsychiatric symptoms (NPI-12). Safety data (fatigue, medication change and compliance) were also recorded. Repeated measures ANCOVAs were applied to outcomes. Both groups significantly ameliorated executive functions overtime as indicated by improvements in DEX-patient and DEX-caregiver scores. PDQ-39 scores decreased at the four-week follow-up in the Psychoeducation/Mindfulness group whereas they were maintained in the Adapted-GMT group. All other measures were maintained over time in both groups. Adapted-GMT and Psychoeducation/Mindfulness groups both improved executive functioning. This is one of the first studies to test home-based approaches, tailored to the participant's cognitive needs, and involving caregivers.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT04636541
Study type Interventional
Source Laval University
Contact
Status Completed
Phase N/A
Start date April 30, 2018
Completion date July 20, 2019

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