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

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ClinicalTrials.gov Identifier: NCT00611312
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : October 3, 2012
Alzheimer's Association
Information provided by (Responsible Party):
Yvonne Colgrove, PT, PhD, University of Kansas

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: Cognitive Training Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease
Study Start Date : February 2008
Primary Completion Date : May 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Brain activity during functional brain imaging [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611312

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Alzheimer's Association
Principal Investigator: Yvonne Colgrove, PhD, PT University of Kansas Medical Center

Responsible Party: Yvonne Colgrove, PT, PhD, Principal Investigator, University of Kansas
ClinicalTrials.gov Identifier: NCT00611312     History of Changes
Other Study ID Numbers: IIRG-07-57789
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by Yvonne Colgrove, PT, PhD, University of Kansas:
Alzheimer's disease
Cognitive training

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders