Alzheimer Disease Clinical Trial
— BEAT-ADOfficial title:
Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study
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. Group 2 will include volunteers who have mild cognitive impairment. This group will complete a 16-week low-fat diet study, with follow-up assessment 8 weeks after diet final completion. Study measures, clinic visits and phone sessions will occur 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 | Recruiting |
Enrollment | 120 |
Est. completion date | April 2026 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebrospinal Fluid (CSF) Abeta42 | CSF Aß42 is a a key AD biomarker that reflects pathological aggregation of amyloid in the brain. | 16 Weeks | |
Secondary | CSF abeta42/ptau ratio | The ratio of CSF Aß42 to tau is a key AD biomarker that reflects an integrated value of amyloid and tau pathology in the brain. | 16 Weeks | |
Secondary | Preclinical Alzheimer Cognitive Composite (PACC) | The PACC consists of Free and Cued Selective Reminding Test - Total Recall, Logical Memory IIa - Delayed Paragraph Recall, Digit Symbol Substitution Test, MMSE - Total Score and Category Fluency. Although the PACC was designed for use with preclinical AD, it is reasonable to assume it will also be sensitive in aMCI, as all PACC components are frequently used in aMCI studies. According to PACC developer, Reisa Sperling, MD, it is a useful indicator of cognitive change in aMCI in the Harvard Aging Brain Study (personal communication). Further, we observed significant improvement in our cognitive test composite that includes 2 PACC components following the MMKD. |
16 Weeks | |
Secondary | Cerebral Blood Flow Measure with Arterial Spin Labeling (ASL) MRI | Cerebral blood flow will be measured with pseudo continuous ASL MRI, and voxel based analyses will be conducted to determine diet-induced changes and their relationship to cognitive and biomarker outcomes. | 16 Weeks |
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