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Lay Description

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

Category

  • Heart, Vascular and Blood
  • Aging and Geriatric
  • Dementia / Alzheimers
IRB Number
20200339HU
NCT Number
NCT04262206
Open to Enrollment
Not set

Eligibility

Eligible Ages
Over 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Community-dwelling adults
  • Age 75 years or older

Exclusion Criteria

  • Clinically evident CVD, defined as prior MI, prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin as determined by their clinician.
  • Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure without clinically evident cardiovascular disease is not an exclusion)
  • Dementia (clinically evident and/or previously diagnosed)
  • Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)
  • Severe hearing impairment (preventing phone follow up)
  • Severe visual impairment (preventing cognitive testing)
  • Statin use in the past year or for longer than 5 years previously (participant reported)
  • Ineligible to take atorvastatin 40 mg (clinician determined)
  • Documented intolerance to statins
  • Active liver disease

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Preston Bridges
bridgesp@uthscsa.edu

Regulatory Point of Contact
Alice Conde
(210) 617-5190
condea@uthscsa.edu

Regulatory Point of Contact
Tiffany Cortes
(210) 450-8998
cortest@uthscsa.edu

Regulatory Point of Contact
Sara Espinoza
(210) 617-5197
espinozas2@uthscsa.edu

Regulatory Point of Contact
Sandra Idar
(210) 450-0568
idars@uthscsa.edu

Regulatory Point of Contact
Diana Jarbeau-may
(210) 617-5190
jarbeaumay@uthscsa.edu

Regulatory Point of Contact
Nicolas Musi
(210) 562-6140
musi@uthscsa.edu

Local Recruitment Point of Contact
Preston Bridges
bridgesp@uthscsa.edu

Local Recruitment Point of Contact
Alice Conde
(210) 617-5190
condea@uthscsa.edu

Local Recruitment Point of Contact
Sara Espinoza
(210) 617-5197
espinozas2@uthscsa.edu

Local Recruitment Point of Contact
Sandra Idar
(210) 450-0568
idars@uthscsa.edu

Principal Investigator
Nicolas Musi