Status:
RECRUITING
Brain Energy for Amyloid Transformation in Alzheimer's Disease Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This study will examine the effects of a 4-month Modified Mediterranean-Ketogenic Diet compared with an American Heart Association Diet (AHAD - a regimen that has been shown to reduce the risk for car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03472664
Start Date
July 16 2018
End Date
April 1 2026
Last Update
July 28 2025
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157