Back to resultsEffects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Cognitive training
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)
Exclusion Criteria:
- Neurologic disorder other than Alzheimer's disease
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cognitive Training
Outcomes
Primary Outcome Measures
Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE
Secondary Outcome Measures
Brain activity during functional brain imaging
Full Information
NCT ID
NCT00611312
First Posted
January 28, 2008
Last Updated
October 2, 2012
Sponsor
University of Kansas
Collaborators
Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT00611312
Brief Title
Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease
Official Title
Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
Alzheimer's Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.
Detailed Description
Twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fMRI). Scanning will be done while subjects perform a verbal learning task. Ten subjects will be scanned before and after the two week training. Another ten will be scanned twice at a two week interval before beginning the cognitive training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, Cognitive training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive Training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day
Primary Outcome Measure Information:
Title
Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE
Time Frame
2 weeks with FU at 2 and 4 months
Secondary Outcome Measure Information:
Title
Brain activity during functional brain imaging
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)
Exclusion Criteria:
Neurologic disorder other than Alzheimer's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Colgrove, PhD, PT
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease
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