Brain Energy for Amyloid Transformation in Alzheimer's Disease Study

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 20, 2018

Keywords

ClinConnect Summary

The Brain Energy for Amyloid Transformation in Alzheimer's Disease (BEAT-AD) study is investigating how two different diets might affect people with mild cognitive impairment, which is a condition that can lead to Alzheimer's disease. Specifically, the study compares a low-carbohydrate ketogenic diet to a low-fat diet over a 16-week period. Researchers want to see if these diets can improve thinking skills, blood flow in the brain, and levels of certain proteins and hormones related to brain health.

To participate, individuals must be diagnosed with mild cognitive impairment and have someone who can help provide information about their condition. Participants will be randomly assigned to one of the two diets and will receive guidance from a dietitian to help plan their meals. Throughout the study, which lasts 24 weeks, participants will have regular check-ins, including clinic visits and phone sessions. After the diet phase, there will be follow-up assessments to see how participants are doing. This study not only aims to gather important data but also offers participants a chance to learn more about healthy eating habits after completing the trial.

Gender

ALL

Eligibility 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