Expired Study
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Kansas City, Kansas 66160


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

IIRG-07-57789


NCT ID:

NCT00611312


Secondary ID:

11008


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Yvonne Colgrove, PhD, PT
Principal Investigator
University of Kansas

Study Dates

Start Date:February 2008
Completion Date:September 2012
Completion Type:Actual
Primary Completion Date:May 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 2, 2012
First Received Date:January 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Brain activity during functional brain imaging
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Training
Description:Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Cognitive Training

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kansas
Agency Class:Other
Agency Type:Collaborator
Agency Name:Alzheimer's Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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