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Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

Primary Purpose

Alzheimer's Disease Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic vs. Non-Aerobic exercise
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer's Disease Prevention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers
  • 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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobics exercise

Non-Aerobics Exercise

Arm Description

Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).

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.

Outcomes

Primary Outcome Measures

Number of Subjects Retained at 6 Months
The number of subjects retained at 6 month end of study time point.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2013
Last Updated
December 21, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01834716
Brief Title
Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobics exercise
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).
Arm Title
Non-Aerobics Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic vs. Non-Aerobic exercise
Primary Outcome Measure Information:
Title
Number of Subjects Retained at 6 Months
Description
The number of subjects retained at 6 month end of study time point.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neill Graff-Radford, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

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Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

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