Comparing ketogenic and low-fat diets for mild cognitive impairment in Alzheimer's disease
Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study
This study is testing whether a ketogenic diet or a low-fat diet can help improve thinking and memory in adults with mild cognitive impairment related to Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03472664 on ClinicalTrials.gov |
What this trial studies
The Brain Energy for Amyloid Transformation in Alzheimer's Disease study will evaluate the effects of a ketogenic low-carbohydrate diet versus a low-fat diet in adults diagnosed with mild cognitive impairment. Participants will be randomly assigned to one of the two diets for a duration of 16 weeks, with follow-up assessments conducted 8 weeks after the diet period. The study aims to measure changes in cognitive function, cerebral blood flow, and specific biomarkers in body fluids, utilizing personalized dietary plans and ongoing support from dietitians. This research seeks to enhance understanding of dietary impacts on Alzheimer's disease and identify potential new therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a diagnosis of amnestic mild cognitive impairment.
Not a fit: Patients with other neurodegenerative diseases or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that may improve cognitive function and slow the progression of Alzheimer's disease.
How similar studies have performed: Previous studies have shown promising results with dietary interventions in cognitive impairment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Clinically significant elevations in liver function tests * Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is permissible) * History of epilepsy or seizure within past year * Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers) * Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Suzanne Craft, PhD — Wake Forest University Health Sciences
- Study coordinator: Karen Gagnon
- Email: Karen.Gagnon@Advocatehealth.org
- Phone: (336) 713-8010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.