Effect of a Modified Ketogenic-Mediterranean Diet on Alzheimer's Disease (BEAM)

This is an interventional treatment trial for Mild Cognitive Impairment Read More

Inclusion Criteria:

1. Male or post-menopausal female;
2. Age 50 to 85 years inclusive;
3. Cognitive diagnosis ranged from cognitively normal for "'Healthy' and 'At-Risk'" to mild/moderate cognitive impairment for "MCI/eAD;"
4. Stable medical condition (generally 3 months prior to screening visit) at the discretion of study physician;
5. Stable on medications (generally 4 weeks prior to screening visit) at the discretion of study physician;
6. Able to complete baseline assessments;
7. HbA1c and fasting glucose within the normal (Healthy or MCI/eAD) or pre-diabetic (At-Risk or MCI/eAD) range depending on group.

Exclusion Criteria:

1. Diagnosis of neurodegenerative illness (except for MCI or early AD in the MCI/eAD group);
2. History of a clinically significant stroke;
3. 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;
4. Sensory impairment (i.e.: visual or auditory) that would preclude the participant from participating in the protocol;
5. Diabetes that requires current use of diabetes medications;
6. Current use of cholesterol/lipid lowering medications;
7. Clinically significant elevations in liver function tests;
8. Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is permissible);
9. History of epilepsy or seizure within past year;
10. Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers);
11. Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease;
12. Use of the following medications: anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics;
13. If female, menstruation in the past 12 months or hysterectomy and current hormone replacement therapy medication;
14. Major digestive disorders, absorption issues, or surgeries that may be exacerbated by diet changes;
15. Untreated hypothyroidism or B12 deficiency;
16. Participants currently using resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (ie: Axona) supplements, or curcumin will be excluded unless they are willing to discontinue them 2 weeks prior to the start of baseline visits and remain off for study duration.