Everyday Memory Impairment in PD-related Cognitive Decline

Running, not enrolling · Not applicable

Conditions studied: Parkinson Disease, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT04474379

Run by

Washington University School of Medicine

People needed

120

Starts

2021-11-29

Expected to finish

2026-09-01

Last updated by the study team

2026-03-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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