Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	University of Kansas Alzheimer's Association
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00611312

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.

Condition	Intervention	Phase
Alzheimer's Disease	Behavioral: Cognitive Training	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease

Further study details as provided by University of Kansas:

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 [ Time Frame: 2 weeks with FU at 2 and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brain activity during functional brain imaging [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cognitive Training	Behavioral: Cognitive Training Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611312

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Alzheimer's Association

Investigators

Principal Investigator:

Patricia Pohl, PhD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Patricia Pohl PhD )
Study ID Numbers:	IIRG-07-57789, 11008
Study First Received:	January 28, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00611312
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Alzheimer's disease
Cognitive training

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 15, 2009