Alzheimer's Prevention Through Exercise

NCT02000583 | Completed Results DMC

• 2 other identifiers: 13376R01AG043962-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; AD; Aerobic Exercise; Exercise

Outcome Measures

Primary Outcomes (1)

• Amyloid Burden

  Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.

  Baseline to 52 weeks

Secondary Outcomes (2)

• Whole Brain Volume

  Baseline to 52 weeks

• Executive Function

  Baseline to Week 52

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks

Other: Aerobic Exercise

Control Group

OTHER

Standard of Care exercise recommendations

Other: Standard of Care

Interventions

Aerobic Exercise OTHER

Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks

Aerobic Exercise Group

Standard of Care OTHER

Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.

Also known as: Standard of Care for exercise recommendations

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Clinical Dementia Rating 0 (nondemented)
• Age 65 or older
• Florbetapir PET evidence of cerebral amyloidosis
• Sedentary or underactive by the Telephone Assessment of Physical Activity
• Stable doses of medications for 30 days.
• Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention

You may not qualify if:

• Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
• Clinically-significant systemic illness that may affect safety or completion of the study
• History of clinically-evident stroke
• Clinically-significant infection within the last 30 days
• Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
• Uncontrolled hypertension within the last 6 months
• History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
• History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
• Insulin-dependent diabetes mellitus
• Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
• Unwillingness to undergo or contraindication to brain MRI scan.
• History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (4)

• Taylor MK, Sullivan DK, Morris JK, Vidoni ED, Honea RA, Mahnken JD, Burns JM. High Glycemic Diet Is Related to Brain Amyloid Accumulation Over One Year in Preclinical Alzheimer's Disease. Front Nutr. 2021 Sep 27;8:741534. doi: 10.3389/fnut.2021.741534. eCollection 2021.

  PMID: 34646853 DERIVED

• Kaufman CS, Honea RA, Pleen J, Lepping RJ, Watts A, Morris JK, Billinger SA, Burns JM, Vidoni ED. Aerobic exercise improves hippocampal blood flow for hypertensive Apolipoprotein E4 carriers. J Cereb Blood Flow Metab. 2021 Aug;41(8):2026-2037. doi: 10.1177/0271678X21990342. Epub 2021 Jan 28.

  PMID: 33509035 DERIVED

• Vidoni ED, Morris JK, Watts A, Perry M, Clutton J, Van Sciver A, Kamat AS, Mahnken J, Hunt SL, Townley R, Honea R, Shaw AR, Johnson DK, Vacek J, Burns JM. Effect of aerobic exercise on amyloid accumulation in preclinical Alzheimer's: A 1-year randomized controlled trial. PLoS One. 2021 Jan 14;16(1):e0244893. doi: 10.1371/journal.pone.0244893. eCollection 2021.

  PMID: 33444359 DERIVED

• Taylor MK, Sullivan DK, Swerdlow RH, Vidoni ED, Morris JK, Mahnken JD, Burns JM. A high-glycemic diet is associated with cerebral amyloid burden in cognitively normal older adults. Am J Clin Nutr. 2017 Dec;106(6):1463-1470. doi: 10.3945/ajcn.117.162263. Epub 2017 Oct 25.

  PMID: 29070566 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jeffrey M. Burns MD
• Organization: University of Kansas Medical Center

jburns2@kumc.edu

913-588-0555

Study Officials

• Jeffrey Burns, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 4, 2013
• Study Start: November 1, 2013
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Locations

US (1)