Trial record 2 of 7 for:    ALZHEIMER DISEASE 14

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. Identifier: NCT01834716
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

Brief Summary:

5.4 million Americans have Alzheimer's disease (AD) costing $185 billion annually, while 15 million caregivers look after these individuals. AD is the sixth leading cause of death, but the only one in the top 10 causes that cannot be prevented.

This study may demonstrate exercise in an amount attainable by many will be preventative in asymptomatic individuals including those with brain Abeta deposition already that are at impending risk of the disease. Sperling and colleagues(1) coined the research term AD-pathophysiological process (abbreviated AD-P) for use in studies such as the intervention in this proposal.

Our long term goal is to assess whether exercise may be preventative of AD at older ages (=73, mean=75), when more than 40% of cognitively normal persons have A beta deposits, the hallmark of AD pathogenesis, in their brains. In a NIH RO1 grant submission the investigators proposed to conduct a partially blinded controlled preventative trial in 150 cognitively normal individuals, randomized in a 2:1 ratio to 18 months of moderate aerobic exercise versus 18 months of toning and stretching. All persons would have baseline and 18 month brain Abeta PET studies. The study was designed to determine whether an exercise intervention in persons mean age 75 would lead to decreased brain Abeta accumulation, increased hippocampal volume, improved cognition, and improved dementia-related biomarkers compared to the control group. The study would be unique in that the investigators would be able to examine if aerobic exercise slows the accumulation of brain Abeta in an older population, at which time Abeta deposition is common. If successful, this would provide an additional motivating reason to recommend exercise for most elderly persons.

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

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

Arm Intervention/treatment
Experimental: Aerobics exercise
Participants in this group will be randomized to aerobics exercise.
Behavioral: Aerobic vs. Non-Aerobic exercise
Experimental: Non-Aerobics Exercise
Participants in this group will be randomized to a non-aerobics exercise group.
Behavioral: Aerobic vs. Non-Aerobic exercise

Primary Outcome Measures :
  1. Number of subjects retained in the study at 6 months [ Time Frame: 6 months ]
    In this pilot study, we will mail to 3,000 persons and determine the response rate, though we will only recruit until 20 volunteers have been successfully randomized. To demonstrate that we can recruit and randomize 20 cognitively normal volunteers to the study, with 14 undergoing aerobic exercise and six undergoing a non-aerobic exercise program. Sixteen volunteers will have positive amyloid findings and four will have negative findings on the CT/PET scan. Two volunteers with negative findings will be in the aerobic exercise group and two will be in the non-aerobic exercise group.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01834716

United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Neill Graff-Radford, MD Mayo Clinic

Responsible Party: Neill R. Graff-Radford, M.D., M.D., Mayo Clinic Identifier: NCT01834716     History of Changes
Other Study ID Numbers: 12-002817
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

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