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Alzheimer's Prevention Through Exercise (APEx)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Standard of Care
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, AD, Aerobic Exercise, Exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Aerobic Exercise Group

Control Group

Arm Description

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

Standard of Care exercise recommendations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Whole Brain Volume
Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
Executive Function
Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.

Full Information

First Posted
November 26, 2013
Last Updated
July 8, 2020
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02000583
Brief Title
Alzheimer's Prevention Through Exercise
Acronym
APEx
Official Title
Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, AD, Aerobic Exercise, Exercise

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Group
Arm Type
Experimental
Arm Description
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Arm Title
Control Group
Arm Type
Other
Arm Description
Standard of Care exercise recommendations
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Standard of Care for exercise recommendations
Intervention Description
Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
Primary Outcome Measure Information:
Title
Amyloid Burden
Description
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.
Time Frame
Baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Whole Brain Volume
Description
Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
Time Frame
Baseline to 52 weeks
Title
Executive Function
Description
Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Burns, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34646853
Citation
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.
Results Reference
derived
PubMed Identifier
33509035
Citation
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.
Results Reference
derived
PubMed Identifier
33444359
Citation
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.
Results Reference
derived
PubMed Identifier
29070566
Citation
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.
Results Reference
derived

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Alzheimer's Prevention Through Exercise

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