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Brain Energy for Amyloid Transformation in Alzheimer's Disease (BEAT-AD)

Recruiting

This study will compare the effects of different diets on cognitive function, brain blood flow, and Alzheimer's biomarkers in adults with mild cognitive impairment (MCI).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
July 16, 2018
April 2023
120

  • Diagnosis of amnestic MCI
  • Study partner who can provide information on participant
  • Stable medical condition (generally 3 months prior to screening)
  • Stable on medications (generally 4 weeks prior to screening)
  • Able to complete baseline assessments

  • Diagnosis of neurodegenerative illness (except for MCI)
  • History of a clinical stroke
  • Current evidence or history in past year of focal brain lesion, head injury with loss of consciousness, or any major psychiatric disorder including psychosis, major depression, bipolar disorder, and alcohol or substance abuse
  • Visual or hearing impairment that would interfere with participation
  • Diabetes that requires medication
  • Clinically significant elevations in liver function tests
  • Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer are permissible)
  • History of epilepsy or seizure within past year
  • Inability to undergo magnetic resonance imaging (e.g., claustrophobia, metal implants in head or mouth, pacemakers)
  • Significant medical illness or organ failure, such as uncontrolled high blood pressure or heart disease, chronic obstructive pulmonary disease, liver disease, or kidney disease

Participants will be randomly assigned to follow either a low-carbohydrate or a low-fat diet for 4 months, with follow-up assessment 8 weeks after diet completion. The diets will be individually planned with help from a study dietitian. In general, the low-carbohydrate, high-fat diet will be a modified Mediterranean-ketogenic diet consisting of fish, lean meats, nutrient-rich foods, olive oil, and less than 20 grams of carbohydrates daily. Participants in the low-fat, high-carbohydrate diet (American Heart Association Diet) will be encouraged to limit fat intake to less than 40 grams per day, while eating plenty of fruits, vegetables, and fiber-containing carbohydrates. All participants will receive a daily multivitamin.

Name City State Zip Status Primary Contact
Wake Forest Baptist Medical Center
Winston-Salem North Carolina 27157 Recruiting Leslie Goordineer
336-713-8477
lgordine@wakehealth.edu

Wake Forest University Health Sciences

  • National Institute on Aging (NIA)

Name Role Affiliation
Suzanne Craft, PhD Principal Investigator Wake Forest University Health Sciences

Name Phone Email
Ashley Sanderlin, PhD 336-713-8817 asanderl@wakehealth.edu

NCT03472664

Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study