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Risk Reduction for Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Risk Reduction for Alzheimer's Disease

Exercise and Intensive Vascular Risk Reduction in Preventing Dementia

NCT02913664•University of Texas Southwestern Medical Center

Summary

Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects of aerobic exercise training and intensive vascular risk reduction on cognitive performance in older adults who have high risk for AD.

Detailed Description

Numerous lines of evidence suggest that interventions that confer therapeutic benefits for cardiovascular health are also associated with improvements in, or preservation of, cognitive function. Many believe "What's good for the heart is good for the brain." However, stronge scientific evidence is needed to prove this hypothesis. The rrAD study is a 4-arm, multicenter, randomized trial to assess the effects of aerobic exercise training and intensive pharmacological reduction of vascular risk factors on cognitive performance in older adults who have high risk for AD, that is, those who have high blood pressure, family history of dementia or subjective memory complaints. Furthermore, rrAD will examine effects of exercise and vascular risk reduction on brain volume, perfusion, and neural network connectivity using magnetic resonance imaging (MRI).

Eligibility

Age

60 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 60-85, all races/ethnicities, and both sexes are eligible.
•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.
•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.
+2 more criteria

Exclusion Criteria

•1. Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction or other brain lesions.
•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.
+13 more criteria

Locations (4)

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

Key Dates

Start Date

February 2, 2017

Primary Completion Date

November 30, 2021

Completion Date

January 31, 2022

Last Updated

February 15, 2022

Enrollment

513

ACTUAL participants

Conditions

Cognitively Normal Older AdultsHypertensionSubjective Cognitive DeclineFamily History of Alzheimer's Disease

Interventions

Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)

DRUG

Aerobic Exercise Training

BEHAVIORAL

Usual Care

OTHER

Stretching Exercise

BEHAVIORAL

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Risk Reduction for Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

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