Actively Recruiting
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
Led by Wake Forest University Health Sciences · Updated on 2026-04-13
120
Participants Needed
1
Research Sites
402 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids. The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study. Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.
CONDITIONS
Official Title
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of amnestic mild cognitive impairment
- An informant (study partner) able to provide collateral information on the participant
- Stable medical condition for at least 3 months before screening, as judged by the study doctor
- Stable on medications for at least 4 weeks before screening, as judged by the study doctor
- Able to complete baseline assessments
You will not qualify if you...
- Diagnosis of neurodegenerative illness other than mild cognitive impairment
- History of significant stroke
- Evidence or history in past year of brain lesion, head injury with loss of consciousness, or major psychiatric disorders including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Sensory impairments that prevent participation
- Diabetes requiring current use of diabetes medications
- Elevated liver function tests
- Active cancer except stable prostate or non-melanoma skin cancer
- History of epilepsy or seizure within past year
- Contraindications to MRI such as claustrophobia, metal implants, or pacemakers
- Significant medical illnesses or organ failure including uncontrolled hypertension, cardiovascular disease, COPD, liver or kidney disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
K
Karen Gagnon
CONTACT
L
Lauren Latham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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