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

What Is This Study About?

This study will compare the effects of different diets on cognition, brain blood flow, and Alzheimer's biomarkers in adults with mild cognitive impairment (MCI). Participants will be randomly assigned to follow either a low-carbohydrate or a low-fat diet for four months, with follow-up assessment eight 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.

Do I Qualify To Participate in This Study?

Must have:

• 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

Must NOT have:

• 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

North Carolina
Wake Forest Baptist Medical Center Winston-Salem, NC 27157 Recruiting Sarah Bohlman, MS 336-716-7354 sarabrow@wakehealth.edu

Who Sponsors This Study?

Lead: Wake Forest University Health Sciences

Collaborator Sponsor

• National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03472664