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Clinical Trials/NCT01834716
NCT01834716
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country16 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease Prevention
Sponsor
Mayo Clinic
Enrollment
16
Locations
1
Primary Endpoint
Number of Subjects Retained at 6 Months
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
December 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neill R. Graff-Radford, M.D.

M.D.

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Subjects Retained at 6 Months

Time Frame: 6 months

The number of subjects retained at 6 month end of study time point.

Study Sites (1)

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