NCT03472664Completed
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 12 Mar 2018
- Start date
- 16 Jul 2018
- Primary completion date
- 19 Jul 2024
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Alzheimer disease
- NCT number
- NCT03472664
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 16 Jul 2018 to the primary completion date, 19 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers)
Other illness
- Diagnosis of neurodegenerative illness (except for MCI);
- History of a clinically significant stroke
- Current evidence or history in past year of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Sensory impairment (i.e.: visual or auditory) that would preclude the participant from participating in the protocol
- Diabetes that requires current use of diabetes medications
- Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is permissible)
- History of epilepsy or seizure within past year
- Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
Other
- Clinically significant elevations in liver function tests
Who the study is looking for
- Diagnosis of amnestic mild cognitive impairment
- An informant (study partner) able to provide collateral information on the participant
- Stable medical condition (generally 3 months prior to screening visit) at the discretion of study physician
- Stable on medications (generally 4 weeks prior to screening visit) at the discretion of study physician
- Able to complete baseline assessments
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.