Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 12-002817
    NCT ID: NCT01834716
    Sponsor Protocol Number: 12-002817

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion 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 and willing to have an MRI and CT/PET scan.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff-Radford, M.D.

Closed for enrollment

Contact information:

Dana Haley

(904)953-2677

Haley.Dana@mayo.edu

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CLS-20119378

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