Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
513 participants
INTERVENTIONAL
2017-02-02
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Aerobic Exercise (Ex)
Aerobic exercise training; blood and cholesterol management will be standard-care by participant's regular doctor.
Aerobic Exercise Training
Participants will take part in a supervised, moderate to vigorous aerobic exercise training program for approximately 24 months. This program consists of exercising 3 times per week for about 30 minutes per session at the beginning, and will increase to 4-5 times per week, 40-50 minutes per session over a period of 4-5 months. Exercise frequency, intensity and duration will be maintained at this level during the rest of the study period.
Usual Care
Participants will follow their regular doctor's recommendations for blood pressure and lipid control.
Intensive Reduction of Vascular Risk Factors (IRVR)
Lowering SBP \< 130 mmHg, administration of atorvastatin 80 mg daily, and stretching exercise.
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) will be used to reduce SBP\<130 mmHg; atorvastatin 80 mg daily will be administered to reduce blood lipid level. Additional antihypertensives may be used if needed.
Intensive Reduction of Vascular Risk Factors (IRVR)
Stretching Exercise
Participants will perform home-based stretching exercise 3 times per week, gradually increased to 4-5 times per week over a period of 4-5 months, and maintained at this level during the rest of the study period. They will be encouraged to attend monthly stretching exercise classes, which will be led by study staff or exercise trainers.
IRVR+Ex
A combination of IRVR and aerobic exercise training.
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) will be used to reduce SBP\<130 mmHg; atorvastatin 80 mg daily will be administered to reduce blood lipid level. Additional antihypertensives may be used if needed.
Intensive Reduction of Vascular Risk Factors (IRVR)
Aerobic Exercise Training
Participants will take part in a supervised, moderate to vigorous aerobic exercise training program for approximately 24 months. This program consists of exercising 3 times per week for about 30 minutes per session at the beginning, and will increase to 4-5 times per week, 40-50 minutes per session over a period of 4-5 months. Exercise frequency, intensity and duration will be maintained at this level during the rest of the study period.
Usual Care
Blood and cholesterol management will be standard-care by participant's regular doctor, and stretching exercise.
Usual Care
Participants will follow their regular doctor's recommendations for blood pressure and lipid control.
Stretching Exercise
Participants will perform home-based stretching exercise 3 times per week, gradually increased to 4-5 times per week over a period of 4-5 months, and maintained at this level during the rest of the study period. They will be encouraged to attend monthly stretching exercise classes, which will be led by study staff or exercise trainers.
Interventions
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Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)
Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) will be used to reduce SBP\<130 mmHg; atorvastatin 80 mg daily will be administered to reduce blood lipid level. Additional antihypertensives may be used if needed.
Intensive Reduction of Vascular Risk Factors (IRVR)
Aerobic Exercise Training
Participants will take part in a supervised, moderate to vigorous aerobic exercise training program for approximately 24 months. This program consists of exercising 3 times per week for about 30 minutes per session at the beginning, and will increase to 4-5 times per week, 40-50 minutes per session over a period of 4-5 months. Exercise frequency, intensity and duration will be maintained at this level during the rest of the study period.
Usual Care
Participants will follow their regular doctor's recommendations for blood pressure and lipid control.
Stretching Exercise
Participants will perform home-based stretching exercise 3 times per week, gradually increased to 4-5 times per week over a period of 4-5 months, and maintained at this level during the rest of the study period. They will be encouraged to attend monthly stretching exercise classes, which will be led by study staff or exercise trainers.
Eligibility Criteria
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Inclusion Criteria
2. a) A positive family history of dementia defined as having at least one first-degree relative with a history of AD or other type of dementia,or b) having subjective cognitive decline.
3. Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia.
4. Must lead a sedentary lifestyle defined by not having an "active" rating on Rapid Assessment of Physical Activity (RAPA), i.e., score below 6 on RAPA.
5. a) Individuals treated for HTN with 110 ≤ SBP ≤ 130 mmHg; or b) Individuals with SBP \> 130 and SBP \< 180 (If an individual, not treated for HTN, has a SBP ≥ 125 mmHg, consider rescreening after 24 hours).
6. Willingness to be randomized into the treatment groups and ability to return to clinic for follow-up visits over 24 months.
7. Fluency in English, adequate visual and auditory acuity to allow neuropsychological testing.
8. Participants must have a regular healthcare provider.
9. Physical ability to undergo exercise training; able to walk 10 minutes without pain.
Exclusion Criteria
2. Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus.
3. Evidence of severe major depression (GDS \> 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology(e.g. psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures.
4. Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure),or other severe medical conditions.
5. History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of \< 30 or \> 110 bpm; taking class I or III anti-arrhythmic drugs including flecanide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in exercise and lowering blood pressure.
6. Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than 110 mmHg, may be rescreened in 1 week.
7. Orthostatic hypotension, defined as the third standing SBP \< 100mmHg, may be rescreened after 2 weeks.
8. History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, or polymyalgia rheumatic.
9. Significant history of alcoholism or drug abuse within the last five years.
10. Uncontrolled diabetes mellitus, defined as hemoglobin A1C \> 7.5%, or requiring insulin treatment.
11. Regularly smoking cigarette within the past year.
12. Women with a potential for pregnancy, lactation/child bearing (2 year post- menopausal or surgically sterile to be considered not child bearing potential).
13. Participant enrolled in another investigational drug or device study, either currently or within the past 2 months.
14. Severe obesity with BMI ≥ 45; clinical judgment should be applied in all cases to assess patient safety and anticipated compliance.
15. Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix "-sartan".
16. Allergy to other study drugs or their ingredients; for example, clinical history or self-reported allergy or intolerance to atorvastatin.
17. Abnormal screening laboratory tests (e.g., liver ALT and AST \> 3 x ULN, CK \> 3 x ULN, GFR \< 30 or Hct \< 28%); may be rescreened after 2 weeks or longer.
18. A medical condition likely to limit survival to less than 3 years.
19. Participant has any condition(s) judged by the study investigator to be medically inappropriate, risky or likely to cause poor study compliance. For example:
1. Plans to move outside the clinic catchment area in the next 2 years;
2. Significant concerns about participation in the study from spouse, significant other, or family members;
3. Lack of support from primary health care provider;
4. Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the study clinic funds for screening or randomization visits;
5. Residence in a nursing home; persons residing in an assisted living or retirement community are eligible if they meet the other criteria.
6. Other medical, psychiatric, or behavioral factors that, in the judgment of the site PI or clinician, may interfere with study participation or the ability to follow the study Protocol.
7. Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study.
20. Lack of approval from participant's regular healthcare providers, i.e. a signed letter of agreement for the participants to be enrolled in rrAD.
60 Years
85 Years
ALL
No
Sponsors
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Texas Health Resources
OTHER
University of Kansas Medical Center
OTHER
Washington University School of Medicine
OTHER
Pennington Biomedical Research Center
OTHER
Michigan State University
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Rong Zhang
Professor of Neurology
Principal Investigators
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Rong Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Jeffrey Keller, PhD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Jeffrey Burns, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Ellen Binder, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Munro Cullum, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Diana Kerwin, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Health Resources
Locations
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University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Washington University in St. Louis
St Louis, Missouri, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Szabo-Reed A, Clutton J, White S, Van Sciver A, White D, Morris J, Martin L, Lepping R, Shaw A, Puchalt JP, Montgomery R, Mahnken J, Washburn R, Burns J, Vidoni ED. COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods. Contemp Clin Trials. 2022 Jul;118:106805. doi: 10.1016/j.cct.2022.106805. Epub 2022 May 27.
Vidoni ED, Kamat A, Gahan WP, Ourso V, Woodard K, Kerwin DR, Binder EF, Burns JM, Cullum M, Hynan LS, Vongpatanasin W, Zhu DC, Zhang R, Keller JN. Baseline Prevalence of Polypharmacy in Older Hypertensive Study Subjects with Elevated Dementia Risk: Findings from the Risk Reduction for Alzheimer's Disease Study (rrAD). J Alzheimers Dis. 2020;77(1):175-182. doi: 10.3233/JAD-200122.
Gottesman RF. To INFINITY and Beyond: What Have We Learned and What Is Still Unknown About Blood Pressure Lowering and Cognition? Circulation. 2019 Nov 12;140(20):1636-1638. doi: 10.1161/CIRCULATIONAHA.119.042827. Epub 2019 Nov 11. No abstract available.
Szabo-Reed AN, Vidoni E, Binder EF, Burns J, Cullum CM, Gahan WP, Gupta A, Hynan LS, Kerwin DR, Rossetti H, Stowe AM, Vongpatanasin W, Zhu DC, Zhang R, Keller JN. Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study). Contemp Clin Trials. 2019 Apr;79:44-54. doi: 10.1016/j.cct.2019.02.007. Epub 2019 Mar 1.
Related Links
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Study Website
Other Identifiers
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RZNIA60
Identifier Type: -
Identifier Source: org_study_id
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