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Status:

NOT_YET_RECRUITING

Multicontext Approach for Cognitive Function in Parkinson Disease

Lead Sponsor:

Washington University School of Medicine

Conditions:

PARKINSON DISEASE (Disorder)

Eligibility:

All Genders

50+ years

Phase:

NA

Brief Summary

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 pre...

Detailed 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 pre...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

    Key Trial Info

    Start Date :

    January 2 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 31 2030

    Estimated Enrollment :

    114 Patients enrolled

    Trial Details

    Trial ID

    NCT07190404

    Start Date

    January 2 2026

    End Date

    August 31 2030

    Last Update

    September 24 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Washington University School of Medicine

    St Louis, Missouri, United States, 63110