NCT01834716

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 29, 2019

Completed
Last Updated

March 29, 2019

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

April 15, 2013

Results QC Date

March 21, 2018

Last Update Submit

December 21, 2018

Conditions

Alzheimer's Disease Prevention

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Retained at 6 Months

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

    6 months

Study Arms (2)

Aerobics exercise

EXPERIMENTAL

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

Behavioral: Aerobic vs. Non-Aerobic exercise

Non-Aerobics Exercise

EXPERIMENTAL

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.

Behavioral: Aerobic vs. Non-Aerobic exercise

Interventions

Aerobic vs. Non-Aerobic exerciseBEHAVIORAL
Aerobics exerciseNon-Aerobics Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Results Point of Contact

Title
Neill Graff-Radford
Organization
Mayo Clinic
graffradford.neill@mayo.edu
9049537103

Study Officials

  • Neill Graff-Radford, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 29, 2019

Results First Posted

March 29, 2019

Record last verified: 2018-12

Locations

US(1)