Everyday Memory Impairment in PD-related Cognitive Decline

NCT04474379 | Active Not Recruiting DMC

• 1 other identifier: 202007054
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will aim enroll participants into our study within 3-6 months after their parent study visit so the investigators can utilize some key data points (e.g. PD-MCI diagnosis, rs-fcMRI data) from that study. PD participants will participate in a single-blind RCT with two treatment arms: process training and strategy training (Fig 4). They will complete pre-training assessment (Pre), be randomized to treatment arm (1:1 ratio stratified by sex), and then complete 8 training sessions over an 8-week period. They will return within 1 week for post-training assessment (Post) and then will complete Follow-up (FU) assessments via web or mailed survey 3 and 6 months after training ends. They will complete a 12mo FU assessment in person in conjunction with their annual parent study visit. HC participants will complete prospective memory assessment at one time point coinciding with (or within 3-6 months of) their parent study visit to determine whether any relationships observed between rs-fcMRI data and prospective memory are specific to PD.

Conditions

Parkinson Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Change in Virtual Week Computer-based Memory Test performance after 5-weeks and 12-month post-intervention.

  A computer-based prospective memory test that simulates a real day where a person has to remember to do tasks.

  Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.

• Change in The Prospective and Retrospective Memory Questionnaire scores after 5-weeks, 3-months, 6-months, and 12-month post-intervention.

  Participant-reported everyday prospective memory

  Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.

• Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.

  A standardized measure that elicits individual goals and rating goal attainment over time

  Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.

Study Arms (2)

Strategy Training

EXPERIMENTAL

Consists of 8-90 minute sessions over 8 weeks. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the therapist teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based) and instructs in their use before and during the training games. In sessions 3-8, the tester tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed. Feedback on accuracy and strategy use are provided after each training game. After completing the training games, the therapist and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the therapist helps the participant develop written action plans to do so. Plans and goals are reviewed and modified, if necessary, at each session.

Behavioral: Strategy Training (Time- and Event- Based)

Process Training

NO INTERVENTION

Consists of 8, 90 minute sessions over 8 weeks. In sessions 1 and 2, the therapist teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3-8, the tester tells the participant that s/he will be practicing both types of tasks in the training games. In all sessions, the participant completes the training games with no strategy instruction from the therapist. Feedback on accuracy is provided after each training game. This is typical of a process training approach and expects that practice of the training tasks will improve prospective memory ability per se or that participants will develop effective strategies for completing prospective memory tasks on their own. At the end of each session, the therapist reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended. Goals are reviewed and modified if necessary.

Interventions

Strategy Training (Time- and Event- Based) BEHAVIORAL

In time-based training, strategic clock-checking behavior is taught by requiring participants to click a button to reveal the virtual time of day. Event-based training involves implementation intention methods.

Strategy Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females over age 50 who meet criteria for typical idiopathic PD
• Hoehn \& Yahr stage I-III,
• Treated with levodopa/carbidopa
• Have subjective memory complaints (as identified in phone screen),
• Have an informant to complete relevant ratings,
• Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); changes over the follow-up period will be tracked and accounted for as appropriate.

You may not qualify if:

• Dementia according to MDS criteria or MoCA score \<21.
• Other neurological disorders (e.g. stroke, seizures), brain surgery, severe systemic diseases, major psychiatric disorder or history of psychotic symptoms (e.g. schizophrenia, bipolar disorder, delusions, hallucinations), or drug abuse.
• Treatment with medications that interfere with cognition (e.g. anticholinergics).
• Any other condition that would interfere with participation (e.g., non-English speaking, significant current depression).
• Psychiatric conditions/ symptoms that are common in PD (e.g. anxiety, depression) are allowed if they are deemed insufficient to interfere with participation.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Interventions

Time

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Erin Foster, PhD, OTD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcomes assessor will be blind to which cognitive training a participant will be randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to treatment arm (1:1 ratio, stratified by sex and Clinical Dementia Rating (CDR) Score 0 or 0.5): the strategy training or the process training.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 16, 2020
• Study Start: November 29, 2021
• Primary Completion: March 12, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 3 months after publication
• Access Criteria: Per individual request to PI.

Locations

US (1)