RECRUITING

Everyday Memory Impairment in PD-related Cognitive Decline

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Memory Impairment in Parkinson Disease-related Cognitive Decline: Intervention and Mechanisms

Quick Facts

Study Start:2021-11-29
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04474379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females over age 50 who meet criteria for typical idiopathic PD
  2. * Hoehn \& Yahr stage I-III,
  3. * Treated with levodopa/carbidopa
  4. * Have subjective memory complaints (as identified in phone screen),
  5. * Have an informant to complete relevant ratings,
  6. * 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.
  1. * Dementia according to MDS criteria or MoCA score \<21.
  2. * 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.
  3. * Treatment with medications that interfere with cognition (e.g. anticholinergics).
  4. * Any other condition that would interfere with participation (e.g., non-English speaking, significant current depression).
  5. * Psychiatric conditions/ symptoms that are common in PD (e.g. anxiety, depression) are allowed if they are deemed insufficient to interfere with participation.

Contacts and Locations

Study Contact

Tasha Doty, MA
CONTACT
3143627160
tdoty@wustl.edu

Principal Investigator

Erin Foster, PhD, OTD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
St. Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Erin Foster, PhD, OTD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-29
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2021-11-29
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Mild Cognitive Impairment