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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01469741
Other study ID # 201103176
Secondary ID
Status Completed
Phase N/A
First received November 8, 2011
Last updated June 1, 2015
Start date June 2011
Est. completion date May 2014

Study information

Verified date June 2015
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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 will use a randomized controlled design and a laboratory-based assessment of prospective memory to test the effect of the strategy in a controlled environment. The investigator will also see if PD participants, with support from an occupational therapist (OT), can generalize the strategy to their complex, real-world environments and tasks. Our goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Prospective Memory Strategy
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.

Locations

Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

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