Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611312
• Other study ID #: IIRG-07-57789
• Secondary ID: 11008
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: October 2, 2012
• Start date: February 2008
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Cognitive Training
Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 weeks with FU at 2 and 4 months	No
Secondary	Brain activity during functional brain imaging		2 weeks	No