NCT03335150

Brief Summary

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 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

November 2, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

3.5 years

First QC Date

October 18, 2017

Results QC Date

May 1, 2020

Last Update Submit

February 5, 2021

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseRehabilitationCognition

Outcome Measures

Primary Outcomes (1)

  • Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score

    The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.

    Baseline and Week 10

Secondary Outcomes (8)

  • Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score

    Baseline and Week 10

  • Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score

    Baseline and Week 10

  • Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score

    Baseline and Week 10

  • Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score

    Baseline and Week 10

  • Memory for Intention Test (MIST) Total Score

    Baseline and Week 10

  • +3 more secondary outcomes

Study Arms (2)

Supportive Care

ACTIVE COMPARATOR

Support Group for PD-MCI

Behavioral: Supportive Care

CogSMART-PD

EXPERIMENTAL

Cognitive Rehabilitation for PD-MCI

Behavioral: CogSMART-PD

Interventions

CogSMART-PDBEHAVIORAL

Cognitive Rehabilitation for persons with PD-MCI

CogSMART-PD
Supportive CareBEHAVIORAL

Support Group for persons with PD-MCI

Supportive Care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's disease
  • Mild Cognitive Impairment
  • Over 40 years of age
  • Fluent English speaker

You may not qualify if:

  • Other neurological conditions (e.g., stroke) besides Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Dawn Schiehser
Organization
VASDHS
Dawn.Schiehser@va.gov
858-552-8585

Study Officials

  • Dawn M. Schiehser, PhD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and Assessor are blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

November 7, 2017

Study Start

November 2, 2015

Primary Completion

April 30, 2019

Study Completion

January 31, 2021

Last Updated

February 23, 2021

Results First Posted

June 4, 2020

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)