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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG043962-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise Group | Experimental | Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks |
|
| Control Group | Other | Standard of Care exercise recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 52 weeks |
| Executive Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Burns, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42024105 | Derived | Smith 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. | |
| 34646853 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerobic Exercise Group | Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks |
| FG001 | Control Group | Standard of Care exercise recommendations Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aerobic Exercise Group | Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Six individuals did not complete follow-up testing due to withdrawal. Two refused follow-up PET. | Posted | Mean | Standard Deviation | Standard Uptake Value Ratio (SUVR) | Baseline to 52 weeks |
|
One year
Adverse events were defined and graded according to CTCAE 3.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aerobic Exercise Group | Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks Aerobic Exercise: Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular Tachycardia | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment | Grade 3 Supraventricular Tachycardia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment | Joint pain - Grade 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey M. Burns MD | University of Kansas Medical Center | 913-588-0555 | jburns2@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2018 | Jun 16, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2016 | Jun 16, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
|
|
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.
| Baseline to Week 52 |
| 33509035 | 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. |
| 33444359 | 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. |
| 29070566 | 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. |
Standard of Care exercise recommendations Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Group |
Standard of Care exercise recommendations Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program. |
|
|
| Secondary | 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. | Six individuals did not complete follow-up testing due to withdrawal. Seven refused follow-up MRI. | Posted | Mean | Standard Deviation | mL | Baseline to 52 weeks |
|
|
|
| Secondary | 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. | Six individuals did not complete follow-up testing due to withdrawal. | Posted | Mean | Standard Deviation | Standard Deviations | Baseline to Week 52 |
|
|
|
| 0 |
| 78 |
| 8 |
| 78 |
| 23 |
| 78 |
| EG001 | Control Group | Standard of Care exercise recommendations Standard of Care: Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program. | 0 | 39 | 4 | 39 | 4 | 39 |
|
| Infection with unknown ANC | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment | Grade 3 Post-surgical infection with unknown |
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| Lower extremity arthroplasty | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment | Grade 3 lower extremity arthroplasty (1 knee, 1 hop |
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| Hepatobiliary inflammation | Hepatobiliary disorders | CTCAE 3.0 | Non-systematic Assessment | Grade 3Ibuprofen toxicity and liver inflammation |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 3.0 | Non-systematic Assessment | Grade 3 Breast Cancer |
|
| Acute Pyelonephritis with urinary tract infection | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment | Grade 3Acute Pyelonephritis with urinary tract infection |
|
| Fall and hip fracture requiring fixation | Injury, poisoning and procedural complications | CTCAE 3.0 | Non-systematic Assessment | Fall and hip fracture requiring fixation Grade 3 |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Follow-up |
|