Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01834716
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 0.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Prevention	Behavioral: Aerobic vs. Non-Aerobic exercise	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobics exercise 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
Experimental: Non-Aerobics Exercise 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

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Retained at 6 Months [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Neill Graff-Radford, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neill R. Graff-Radford, M.D., M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01834716
• Other Study ID Numbers: 12-002817
• First Posted: Apr 18, 2013
• Last Update Posted: Mar 29, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Recruitment Details	Participants were recruited via study invitations mailed to persons by age and zip code. Local community presentations were also conducted to recruit subjects.

Arm/Group Title	Non-Aerobics Exercise	Aerobics Exercise
Arm/Group 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.	Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
Period Title: Overall Study
STARTED	4	12
COMPLETED	4	11
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Non-aerobics Exercise	Aerobics Exercise	Total
Arm/Group Description	Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week).	Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).	Total of all reporting groups
Overall Participants	4	12	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	4 100%	12 100%	16 100%
Sex: Female, Male (Count of Participants)
Female	3 75%	4 33.3%	7 43.8%
Male	1 25%	8 66.7%	9 56.3%
Region of Enrollment (participants) [Number]
United States	4 100%	12 100%	16 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aerobics Exercise	Non-Aerobics Exercise
Arm/Group Description	Participants in this group will be randomized to aerobics exercise. Aerobic vs. Non-Aerobic exercise 12 enrolled 11 completed	Participants in this group will be randomized to a non-aerobics exercise group. Aerobic vs. Non-Aerobic exercise 4 enrolled and 4 completed
Measure Participants	11	4
Count of Participants [Participants]	11 275%	4 33.3%

Adverse Events

Time Frame	Adverse events were collected at baseline, 3 months, and 6 months.
Arm/Group Title	Aerobics Exercise		Non-Aerobics Exercise
Arm/Group 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 exercise group (attending classes of toning and stretching a minimum of three times per week).
All Cause Mortality
	Aerobics Exercise		Non-Aerobics Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/4 (0%)
Serious Adverse Events
	Aerobics Exercise		Non-Aerobics Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/4 (0%)
General disorders
Cancer	1/12 (8.3%)	1	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	Aerobics Exercise		Non-Aerobics Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.