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Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

This study is currently recruiting participants.
Verified by Intermountain Health Care, Inc., November 2006

Sponsors and Collaborators: Intermountain Health Care, Inc.
Deseret Foundation
Information provided by: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00403507
  Purpose

The purpose of the study is to determine if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities (e.g., husband, wife, adult child, or caregiver).


Condition Intervention Phase
Alzheimer Disease
Memory Disorders
Dementia
Behavioral: Participation in a monitored exercise program
Phase II

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Dementia    Exercise and Physical Fitness    Memory   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • For the intervention group: Change in cognitive performance relative to baseline
  • Group differences in cognitive performance following intervention and relative to wait-list control group
  • For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline
  • Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group

Secondary Outcome Measures:
  • For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes
  • Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group

Estimated Enrollment:   79
Study Start Date:   October 2006
Estimated Study Completion Date:   July 2008

Detailed Description:

Currently, there is no cure for the memory loss associated with Alzheimer's disease, though some medications can help it from getting worse. The research study will help to answer the question if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities.

The research study is a randomized-control trial: some participants will be picked to participate in the exercise program, while others will not. Their memory, thinking abilities, activities, and attitudes will be measured at baseline and follow-up assessment 5-6 months later. Participants are in good health, and are treated with a cholinesterase inhibitor for memory loss (standard treatment).

  Eligibility
Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age is 65 through 89 years old.
  • Completed more than an 8th grade education.
  • Native English speaker.
  • Diagnosis of probable Alzheimer's disease by a primary care physician or specialty clinic.
  • Taking a cholinesterase inhibitor at a therapeutic dose for at least two weeks prior to admission to study (following minimum titration of four weeks), but no other prescribed medication for cognitive functioning (e.g., memantine/Namenda).
  • May have one unstable physical illness that is being treated or a few controlled physical illnesses, is on few medications, and appears no more than mildly ill.
  • Treated stable hypertension & hyperlipidemia are permissible, but resting blood pressure must be <170/100 mm Hg.
  • Normal TSH & Vitamin B12 levels, as confirmed by laboratory data within 3 years.
  • Able to participate a three-day/week physical activity program (No orthopedic, neurologic, or behavioral limitations that may preclude exercise training) for up to 6 months.
  • Patient has a knowledgeable informant who can report the day-to-day activities of participant (e.g., spouse, adult child, paid caregiver).
  • Able to give assent/consent to research study.

Exclusion Criteria:

  • History of learning or developmental disability.
  • Treatment with hormone replacement therapy during the last year.
  • History of psychiatric condition (including depression).
  • Evidence of serious cardiac condition or significant small vessel disease (e.g., heart bypass surgery, angina, arrhythmia, dyspnea, insulin-dependent diabetes with neuropathy, confluent white matter alterations on structural MRI or CT scan).
  • History of neurologic condition (e.g., large vessel stroke, seizures, Parkinsonism).
  • History of heavy metals exposure.
  • History of sleep disturbance (e.g., treated apnea, insomnia).
  • History of brain injury (including concussion of >10 minutes).
  • History of delirium (change in mental status due to medications) for the past year.
  • No pharmaceutical treatment for mood currently, or history of longstanding depression.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403507

Contacts
Contact: Kelly Garrett, Ph.D.     801-408-5498     KellyDavisGarrett@intermountainmail.org    
Contact: Cherie P Brunker, M.D.     801-408-8600    

Locations
United States, Utah
LDS Hospital     Recruiting
      Salt Lake City, Utah, United States, 84143
      Contact: Kelly Garrett, Ph.D.     801-408-5498     KellyDavisGarrett@intermountainmail.org    
      Contact: Cherie P Brunker, M.D.     801-408-8600        
      Principal Investigator: Kelly Garrett, Ph.D.            

Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation

Investigators
Principal Investigator:     Kelly Garrett, Ph.D.     Intermountain Health Care- LDS Hosptial    
  More Information


Answers to questions about participation in research study, and screening form for prospective participants to complete with their health care provider.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   Kelly Garrett
First Received:   November 21, 2006
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00403507
Health Authority:   United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Mild Dementia  
Mild Alzheimer  
Cognitive Impairment  
Cholinesterase Inhibitor  
Exercise
Physical activity
Behavior
Memory loss

Study placed in the following topic categories:
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Memory Disorders
Cognition Disorders
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Amnesia
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 03, 2008




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