RECRUITINGINTERVENTIONAL

Brain Energy for Amyloid Transformation in Alzheimer's Disease Study

Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

low carbohydrate/high fat diet

Modified Mediterranean-Ketogenic Diet is a low carbohydrate/high fat diet.

OTHER

low fat/high carbohydrate diet

American Heart Association Diet is a low fat/high carbohydrate diet.

Locations (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States