NCT07190404 · Washington University School of Medicine
Multicontext Approach for Cognitive Function in Parkinson Disease
(MC4PD R01)
What this study is about
Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem.
View original scientific description
Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem. Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD. Study participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.
Interventions
BEHAVIORAL
A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach.
The Multicontext Approach is a strategy training approach to cognitive intervention provides ways to maintain daily function despite the presence of cognitive deficits. It involves teaching people to use metacognitive, compensatory, or adaptive techniques to optimize information processing or bypass cognitive limitations and achieve task-related goals. Strategy training is recommended for those with mild (vs. more severe) cognitive deficits because it requires learning, capitalizes on existing cognitive resources, and aims to prevent or delay functional decline.
BEHAVIORAL
Cognitive (Process) Training
This treatment is functional task training, a widely-used approach in neurorehabilitation153,154 that parallels the cognitive training used in PD to-date but with functional cognitive tasks (vs. computer or paper \& pencil tasks) to improve ecological validity. It has the same structure within and across treatment sessions and uses the same treatment activities as the MC intervention. However, the OT does not use mediated learning techniques or explicitly address strategies, metacognition, or transfer/generalization. Rather, participants practice functional cognitive tasks with knowledge of results feedback and cueing by the OT to improve task performance.
BEHAVIORAL
MC Approach Booster Session
MC+B participants will come from the MC Approach group only. They will receive 2 additional treatment sessions with their original OT within the month following their 6mo FU assessment. The OT will review the participant's relevant Post and FU data beforehand for treatment planning purposes. The first session will involve a review of goals, prior learning, and strategies and discussion of successes/challenges related to functional cognitive performance and strategy application since initial treatment. Then the same protocol (treatment activities with metacognitive framework and mediation, strategy bridging discussions, homework action planning and review) will be followed for the rest of the booster treatment to reinforce or re-activate prior learning, address new concerns, and develop supports for maintenance.
Primary outcome measures
Bangor Goal Setting Interview
Time frame: Goals will be assessed during the intervention at 2- and 4-weeks after Baseline testing; at POST intervention 11-weeks after Baseline; then one year from the final intervention session (63-weeks after Baseline).
A standardized cognitive rehabilitation tool to identify functional cognitive problems and develop treatment goals. Participants rate their goal attainment on a scale from 0 (not successful) to 10 (very successful); readiness to work on the specific goal on a scale of 0 (not ready to change) to 10 (Extremely ready to change); and the importance of the goal to them on a scale from 0 (not important) to 10 (extremely important).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females over age 50 who meet criteria for typical idiopathic PD.
- Hoehn \& Yahr stage I-III.
- Have subjective cognitive decline (SCD) as defined by a positive answer to either question:
- Do you feel like your thinking skills or memory are becoming worse or are worse than others your age?
- Do you have problems or concerns with your thinking skills or memory?, and can list ≥1 daily cognitive challenge they want to address.
- Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); unplanned changes and changes over the follow-up period will be tracked and accounted for as appropriate.
Exclusion criteria
- Dementia according to MDS criteria or MoCA score \<21.
- Other neurological disorders (e.g., stroke, seizures).
- Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions/symptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation.
- Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives \>50mi away).
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations