Trial record 2 of 6 for:    ALZHEIMER DISEASE 14

Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01834716
First received: April 15, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Alzheimer's Disease Prevention
Behavioral: Aerobic vs. Non-Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of subjects retained in the study at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: NCT01834716

Contacts
Contact: Dana L Haley, MPH (904) 953-9680 haley.dana@mayo.edu

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Dana L Haley, MPH    904-953-9680    haley.dana@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Neill Graff-Radford, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Neill R. Graff-Radford, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01834716     History of Changes
Other Study ID Numbers: 12-002817
Study First Received: April 15, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014