We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01834716
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Prevention Behavioral: Aerobic vs. Non-Aerobic exercise Not Applicable

Detailed Description:

After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire.

Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study/ 18F-AV-45-A14 - CLINICAL EVALUATION OF FLORBETAPIR F 18 (18F-AV-45) Sponsor of 18F-AV-45-A14: Avid Radiopharmaceuticals
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Aerobics exercise
Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).
 Behavioral: Aerobic vs. Non-Aerobic exercise
Experimental: Non-Aerobics Exercise
Participants in this group will be randomized to a non-aerobics (attending classes of toning and stretching a minimum of three times per week) exercise group.
 Behavioral: Aerobic vs. Non-Aerobic exercise


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Subjects Retained at 6 Months [ Time Frame: 6 months ]
    The number of subjects retained at 6 month end of study time point.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 65 years of age or older.
  • Not diagnosed with memory problems.
  • Do not exercise in which you sweat and/or raise your pulse rate more than 30 minutes two times per week.
  • Able to walk ten blocks (about one mile).
  • Willing to participate in weekly exercise classes at the Brooks YMCA for six months.
  • Able to have an MRI and CT/PET scan.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01834716


Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Neill Graff-Radford, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Neill R. Graff-Radford, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01834716    
Other Study ID Numbers: 12-002817
First Posted: April 18, 2013    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders