Multicontext Approach for Parkinson's Disease
(MC4PD R01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to assist people with early-stage Parkinson's disease experiencing worsening thinking or memory. The focus is on teaching strategies to manage everyday cognitive challenges, aiming to improve quality of life, unlike past methods that offered limited help. Participants will work with occupational therapists over several sessions to develop these strategies. It suits those with Parkinson's who feel their cognitive skills are declining and can identify daily cognitive challenges they want to tackle.
As an unphased trial, this study offers a unique opportunity to explore innovative strategies that could significantly enhance participants' daily living.
Will I have to stop taking my current medications?
You don't have to stop taking your current medications, but they should be stable for 4 weeks before starting the study and remain unchanged during the treatment sessions.
What prior data suggests that the Multicontext Approach is safe for people with Parkinson's Disease?
Research has shown that the Multicontext Approach is safe and well-tolerated for people with Parkinson's Disease. An initial study reported no negative side effects, and participants completed the treatment sessions successfully. The approach proves practical and acceptable for those who try it. This includes the version with extra booster sessions, which earlier trials also found to have no safety issues. Overall, the Multicontext Approach maintains a strong safety record in studies to date.12345
Why are researchers excited about this trial?
Researchers are excited about the Multicontext Approach for Parkinson's Disease because it takes a comprehensive method that goes beyond typical medication or physical therapy. Unlike standard treatments that mainly focus on managing symptoms, this approach addresses cognitive challenges by involving various contexts to improve everyday functioning. The MC + Booster variant even adds additional sessions to reinforce skills, which could lead to longer-lasting benefits. This innovative method aims to offer a more holistic way to enhance the quality of life for people with Parkinson's.
What evidence suggests that the Multicontext Approach is effective for cognitive decline in Parkinson's disease?
Studies have shown that the Multicontext Approach, a method to improve thinking skills, can help people with Parkinson's Disease (PD) who do not have dementia. This approach increases awareness of thinking and teaches strategies to manage daily tasks better. In this trial, researchers will divide participants into groups: one group will receive the Multicontext Approach, while another will undergo cognitive process training as a control. Some participants from the Multicontext Approach group will also receive extra follow-up sessions, which might lead to even greater benefits. Overall, the Multicontext Approach appears promising for enhancing daily function and quality of life in individuals with PD who face thinking challenges.12367
Who Is on the Research Team?
Erin R Foster, PhD, OTDR/L
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals with early Parkinson's Disease who experience mild cognitive decline. Participants will work with an occupational therapist and must be able to attend multiple treatment sessions and follow-up visits over a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a baseline cognitive testing session
Treatment
Participants receive 10 cognitive treatment sessions with a trained occupational therapist
Follow-up
Participants are monitored for safety and effectiveness after treatment
Booster Treatment
MC+B group receives 2 additional booster treatment sessions to review and reinforce learning and strategy use
What Are the Treatments Tested in This Trial?
Interventions
- Multicontext Approach
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor