Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)

Amanda N. Szabo-Reed, Eric Vidoni, Ellen F. Binder, Jeffrey Burns, C Munro Cullum, William P. Gahan, Aditi Gupta, Linda S Hynan, Diana Rose Kerwin, Heidi Rossetti, Ann M Stowe, Wanpen Vongpatanasin, David C. Zhu, Rong Zhang, Jeffrey N. Keller

Research output: Contribution to journalArticle

Abstract

Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664

Original languageEnglish (US)
Pages (from-to)44-54
Number of pages11
JournalContemporary Clinical Trials
Volume79
DOIs
StatePublished - Apr 1 2019

Fingerprint

Risk Reduction Behavior
Multicenter Studies
Blood Vessels
Dementia
Alzheimer Disease
Clinical Trials
Brain
Cholesterol
Exercise
Blood Pressure
Hypertension
Critical Care
Hypercholesterolemia
Cognition
Atrophy
vascular factor
Perfusion
Obesity
Pharmacology

Keywords

  • Alzheimer's disease
  • Brain structure
  • Cognition
  • Exercise
  • Reduction of vascular risk factors

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study). / Szabo-Reed, Amanda N.; Vidoni, Eric; Binder, Ellen F.; Burns, Jeffrey; Cullum, C Munro; Gahan, William P.; Gupta, Aditi; Hynan, Linda S; Kerwin, Diana Rose; Rossetti, Heidi; Stowe, Ann M; Vongpatanasin, Wanpen; Zhu, David C.; Zhang, Rong; Keller, Jeffrey N.

In: Contemporary Clinical Trials, Vol. 79, 01.04.2019, p. 44-54.

Research output: Contribution to journalArticle

Szabo-Reed, Amanda N. ; Vidoni, Eric ; Binder, Ellen F. ; Burns, Jeffrey ; Cullum, C Munro ; Gahan, William P. ; Gupta, Aditi ; Hynan, Linda S ; Kerwin, Diana Rose ; Rossetti, Heidi ; Stowe, Ann M ; Vongpatanasin, Wanpen ; Zhu, David C. ; Zhang, Rong ; Keller, Jeffrey N. / Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study). In: Contemporary Clinical Trials. 2019 ; Vol. 79. pp. 44-54.
@article{3b410d9151934a42b4535a2563977364,
title = "Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)",
abstract = "Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664",
keywords = "Alzheimer's disease, Brain structure, Cognition, Exercise, Reduction of vascular risk factors",
author = "Szabo-Reed, {Amanda N.} and Eric Vidoni and Binder, {Ellen F.} and Jeffrey Burns and Cullum, {C Munro} and Gahan, {William P.} and Aditi Gupta and Hynan, {Linda S} and Kerwin, {Diana Rose} and Heidi Rossetti and Stowe, {Ann M} and Wanpen Vongpatanasin and Zhu, {David C.} and Rong Zhang and Keller, {Jeffrey N.}",
year = "2019",
month = "4",
day = "1",
doi = "10.1016/j.cct.2019.02.007",
language = "English (US)",
volume = "79",
pages = "44--54",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)

AU - Szabo-Reed, Amanda N.

AU - Vidoni, Eric

AU - Binder, Ellen F.

AU - Burns, Jeffrey

AU - Cullum, C Munro

AU - Gahan, William P.

AU - Gupta, Aditi

AU - Hynan, Linda S

AU - Kerwin, Diana Rose

AU - Rossetti, Heidi

AU - Stowe, Ann M

AU - Vongpatanasin, Wanpen

AU - Zhu, David C.

AU - Zhang, Rong

AU - Keller, Jeffrey N.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664

AB - Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664

KW - Alzheimer's disease

KW - Brain structure

KW - Cognition

KW - Exercise

KW - Reduction of vascular risk factors

UR - http://www.scopus.com/inward/record.url?scp=85062222085&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85062222085&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2019.02.007

DO - 10.1016/j.cct.2019.02.007

M3 - Article

C2 - 30826452

AN - SCOPUS:85062222085

VL - 79

SP - 44

EP - 54

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

ER -