Alzheimer's DiseaseAPExNCT02000583
Alzheimer's Prevention Through Exercise
A study testing Aerobic Exercise in people with Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
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
- Being tested
- Aerobic Exercise, Standard of Care
- Keywords
- Alzheimer's Disease, AD, Aerobic Exercise, Exercise
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
Standard of CareOther
Also called Standard of Care for exercise recommendations
Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks Receives: Other: Aerobic Exercise |
| Control Group | Other | Standard of Care exercise recommendations Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 52 weeks
Secondary outcomes (2)
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.
Measured: Baseline to 52 weeks
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.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Burns, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000583
- Sponsor's protocol ID
- 13376
- Other IDs
- R01AG043962-01
- Acronym
- APEx
- Status last verified
- Jul 2020
- First submitted
- 26 Nov 2013
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Christifano DN, Kelly E, Sands SA, Honea RA, Morris JK, Burns JM, Taylor MK. Omega-3 fatty acids and Alzheimer's disease-related brain biomarkers in older adults enriched for preclinical Alzheimer's disease. Prostaglandins Leukot Essent Fatty Acids. 2026 Jul 25;210:102762. doi: 10.1016/j.plefa.2026.102762. Online ahead of print.
PubMed 42508318Smith AN, Burns JM, Sullivan DK, Morris JK, Carbuhn AF, Herda TJ, Thyfault JP, Taylor MK. Larger baseline body stature predicts one-year amyloid change in cognitively normal older adults enriched with elevated amyloid status. J Alzheimers Dis. 2026 Jun;111(4):1881-1891. doi: 10.1177/13872877261445598. Epub 2026 Apr 23.
PubMed 42024105Taylor 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.
PubMed 34646853Kaufman 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.
PubMed 33509035Vidoni 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.
PubMed 33444359Taylor 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.
PubMed 29070566
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02000583
- Acronym / sponsor ID
- APEx / 13376
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, AD, Aerobic Exercise, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2013
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 28 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Other: Aerobic ExerciseExercise 150 minutes per week (over 3 to 5 days) for 52 weeks |
| Control Group | Other | Other: Standard of CareStandard of Care exercise recommendations |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks | Other | Aerobic Exercise Group |
| Standard of CareAlso: Standard of Care for exercise recommendationsControl group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program. | Other | Control Group |
Primary outcome
Amyloid Burden
Time frame: Baseline to 52 weeks
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.
2 secondary outcomes
Whole Brain Volume
Time frame: Baseline to 52 weeks
Executive Function
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42508318Christifano DN, Kelly E, Sands SA, Honea RA, Morris JK, Burns JM, Taylor MK. Omega-3 fatty acids and Alzheimer's disease-related brain biomarkers in older adults enriched for preclinical Alzheimer's disease. Prostaglandins Leukot Essent Fatty Acids. 2026 Jul 25;210:102762. doi: 10.1016/j.plefa.2026.102762. Online ahead of print.
- Derived from this study: PubMed 42024105Smith AN, Burns JM, Sullivan DK, Morris JK, Carbuhn AF, Herda TJ, Thyfault JP, Taylor MK. Larger baseline body stature predicts one-year amyloid change in cognitively normal older adults enriched with elevated amyloid status. J Alzheimers Dis. 2026 Jun;111(4):1881-1891. doi: 10.1177/13872877261445598. Epub 2026 Apr 23.
- Derived from this study: PubMed 34646853Taylor 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.
- Derived from this study: PubMed 33509035Kaufman 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.
- Derived from this study: PubMed 33444359Vidoni 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.
- Derived from this study: PubMed 29070566Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Burns, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid Burden (time frame: Baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000583, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.