NCT01469741

Brief Summary

Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator's goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

2.9 years

First QC Date

November 8, 2011

Last Update Submit

June 1, 2015

Conditions

Interventions

Prospective memory is central to performance in everyday life as it serves to bind together goal-directed actions and enables people to carry out their plans and wishes meaningfully and appropriately. Everyday prospective memory tasks include remembering to run errands, keep appointments, and turn off the stove after using it.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr39 stage I-III (mild-moderate disease) and are treated with levodopa/carbidopa.

You may not qualify if:

  • Possible dementia,
  • treatment with certain medications that interfere with cognition (e.g., anticholinergics),
  • change in medications over the study period, other neurological disorders, brain surgery (e.g., STN DBS),
  • history of psychotic disorder or significant current psychiatric disorder, or any condition that would interfere with testing (e.g., vision problems).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Erin Foster, OTD, OTR/L

    Washington University School of Medicine, Department of Occupational Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Occupational Therapy, Neurology and Psychiatry

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations