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

This study has been completed.
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Yvonne Colgrove, PT, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00611312
First received: January 28, 2008
Last updated: October 2, 2012
Last verified: October 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 25
Study Start Date: February 2008
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Yvonne Colgrove, PhD, PT University of Kansas
  More Information

No publications provided

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, 11008
Study First Received: January 28, 2008
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Alzheimer's disease
Cognitive training

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 21, 2014