Study to Evaluate Coconut Oil for Alzheimer's Disease

This is a randomized, double-blind, placebo-controlled, cross over study to determine the
efficacy of coconut oil (a proprietary blend of coconut and medium chain triglyceride oils,
administered orally three times daily) to subjects with Alzheimer's disease who have been
screened for ApoE 4 allele. The study medication formula is Cognate Nutritionals Fuel for
Thought™.

Approximately 65 subjects will be treated with a coconut oil beverage (Fuel for Thought™) or
placebo for three months, and then given a 3-5 day interim wash out period. After this,
subjects will resume with three months treatment in opposite treatment arm. Total treatment
period is 6 months.

Inclusion Criteria:

- Men and women aged 55 to 90 years with a diagnosis of mild to moderate Alzheimer's
disease

- Informed consent signed and dated by subject (or legally authorized representative).

- Subjects must have a study partner must also consent to participate in the study, who
they spend at least 10 hours/week with during the study. The study partner must
attend applicable clinic visits and provide information about the subject.

- Subject must have a screening Mini-Mental State Examination score of 16-26.

- Subjects must have a Rosen Modified Hachinski Ischemic score of ≤4.

- Subject must undergo ApoE genetic laboratory testing at the baseline visit.

- Subject must be willing and able to take study medication (or placebo) for the
duration of the study.

- Subject must be stable on all memory enhancing medications including cholinesterase
inhibitors (including donepezil, rivastigmine, and galantamine) and NMDA antagonist
(memantine) for at least 3 months prior to screening and agree not to change these
medications during the course of their participation, unless medically necessary.

- Subject must be stable on all memory enhancing nonprescription supplements (including
gingko biloba, huperzine, resveratrol, or docosahexaenoic acid) for at least 3 months
prior to screening and agree not to change these medications during the course of
their participation.

- As judged by Investigator, the subject and study partner will be compliant and have a
high probability of completing the study, including all scheduled evaluations and
required tests.

- Be fluent in English.

Exclusion Criteria:

- Has significant neurological or medical disease, other than AD, that may affect
cognition, for example, history or evidence of hydrocephalus, or uncontrolled hypo-
or hyperthyroidism.

- Current, clinically significant major psychiatric disorder (eg, major depressive
disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th
Edition (DSMIV), or symptoms (eg, hallucinations) that could affect the subject's
ability to complete the study.

- Geriatric depression scale score of more than 6 or has suicidal ideation.

- Current clinically significant chronic illness that is likely to result in
deterioration of the subject's condition or affect the subject's safety during the
study, including uncontrolled diabetes. Subjects with a history of diabetic
ketoacidosis will also be excluded. Other cases of diabetes will be decided at the
discretion of the study physicians. Subjects with diabetes controlled with exercise
and diet may be screened and admission to study will depend on their screening safety
laboratory assessments.

- History of clinically evident stroke or history of clinically significant carotid or
vertebrobasilar stenosis or plaque and other risk factors for thromboembolic stroke
(e.g atrial fibrillation, clinically significant low ventricular output, atrial
septal defect).

- History of seizures.

- Clinically significant infection within the last 30 days (eg, chronic persistent or
acute infection [eg, upper respiratory infection, urinary tract infection]),prior to
screening.

- Myocardial infarction within the last 2 years.

- Abnormal screening visit electrocardiogram (ECG), in the opinion of the investigator.

- Uncontrolled hypertension within the last 6 months prior to screening.

- History of cancer within the last 3 years, with the exception of nonmetastatic basal
cell carcinoma and squamous cell carcinoma of the skin. (Note: cancer must be in
remission with no signs of progression.)

- Use of experimental or other investigational medications/devices for treatment within
90 days prior to screening.

- Laboratory findings of fasting total cholesterol greater than or equal to 240 mg/dL

- Laboratory findings of fasting triglycerides greater than or equal to 200 mg/dL

- Laboratory findings of fasting glucose greater than or equal to 126 mg/dL

- Other clinically significant abnormality on physical, neurological, laboratory, vital
signs, or ECG examination (eg, changes consistent with recent infarction, ischemia,
clinically significant arrhythmias and clinically significant conduction defects)
that could be detrimental to the subject or compromise the study.

- Does not have adequate venous access that would allow blood draws.

- Subject or study partner is related to study personnel.

- Subjects who have taken coconut oil as a supplement within the last 30 days.

- Subjects who have taken Axona™ within the last 30 days.

- Women who are pregnant. (Women who are of child bearing potential must take
precautions to not become pregnant during the study.)