Efficacy and Safety of MMFS in Mild AD

This is a phase 2 study in patients with probable mild Alzheimer's disease. The study is a
randomized, double-blind, placebo controlled, parallel group design, in which participants
(up to 6 per arm; 12 total) will receive oral placebo or MMFS twice daily for 24 weeks.
Randomized patients and their informants (required) will complete 3 assessments total: at
baseline (prior to taking any study tablets), 12 weeks, and 24 weeks. At each of the three
assessments, participants will complete cognitive and behavioral measures and clinical
interviews, a blood sample will be collected for safety and biomarkers related to Alzheimer's
disease, and the informant will complete an interview concerning the patient's cognition,
mood, and function. Cerebrospinal fluid (CSF) samples will also be obtained from patients via
lumbar puncture at baseline and Week 24 for biomarker analyses. A range of safety and
tolerability assessments will also be performed (including vital signs, laboratory tests, and
ECGs). Participants will be contacted by phone between clinical assessments for monitoring.

Inclusion Criteria:

- Diagnosis of probable Alzheimer's disease (AD)

- ≥ 60 and ≤ 85 years old at screening

- Systolic blood pressure below 150

- Total body weight (bw) must be ≥50 kg and ≤100 kg, and lean body mass (LBM) must be ≤
85 kg

- Mini Mental State Examination (MMSE) = 18-24

- Clinical Dementia Rating: home & hobbies, personal care, or community affairs > 0.

- Neuropsychiatric Inventory (NPI) 12-item score ≥ 7, with following criteria:

- NPI score for inclusion cannot be only from Apathy/Indifference and/or Appetite
and Eating Disorders categories

- Symptoms cannot due to recent life event (accident, loss of loved one,
environmental disturbance, etc.)

- if baseline visit is within 14 days of screen visit, screen visit NPI score can
be used as baseline NPI score

- Evidence of recent-onset symptoms and progressive decline occurring after the age 55

- Cognitive concern reflecting a change in cognition reported by patient or
informant or clinician (i.e., historical or observed evidence of decline over
time)

- Apart from clinical diagnosis of Mild AD, subject must be in good health and capable
of completing all study requirements

- Must be fluent in English

- Must have a friend/family member who frequently spends time with the subject (≥10
hours per week), and is willing to serve as an informant, and accompany the subject
to, and participate in, all laboratory visits

- Completion of at least 12 years of formal education (i.e., possess high school
diploma, GED, or equivalent)

- Hearing and vision ability sufficient to complete neurocognitive testing

Exclusion Criteria:

- Females of child-bearing potential, as defined as menstruation within past 12 months.
Surgically sterile is considered not of child-bearing potential

- Severe physical disability not associated with cognitive function that limits ability
to complete neurocognitive testing (e.g., severe tremor, debilitating arthritis)

- History of evidence of acute or sub-acute micro or macrohemorrhage, greater than 4
microhemorrhages, cortical infarct, or greater than one 1 lunar infarct

- Evidence of vascular dementia (Modified Hachinski Ischemia Scale score >5)

- Stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the
past 1 year)

- Seizure in the past 3 years

- An affirmative response on the C-SSRS, indicating suicidal ideation with intent, with
or without a plan or method, or suicidal behavior, in the past 6 months.

- Clinically significant psychiatric illness in past 6 months requiring hospitalization

- History or diagnosis of any of the following sleep conditions:

- Narcolepsy

- Cataplexy (familial or idiopathic)

- Circadian Rhythm Sleep Disorder

- Primary Hypersomnia

- Diagnosed with apnea but not using Continuous Positive Airway Pressure (CPAP) or
Bilevel Positive Airway Pressure (BIPAP). If diagnosed with apnea, subject must
maintain use of device throughout study

- History of clinically important carotid or vertebrobasilar stenosis or plaque

- Within 1 year before the screening or between screening and baseline, any of the
following: myocardial infarction; moderate or severe congestive heart failure, New
York Heart Association class III or IV; hospitalization for, or symptom of, unstable
angina; syncope due to orthostatic hypotension or unexplained syncope; known
significant structural heart disease (eg, significant valvular disease, hypertrophic
cardiomyopathy), or hospitalization for arrhythmia; congenital QT prolongation

- Current serious or unstable clinically important systemic illness that, in the
judgment of the investigator, is likely to affect cognitive assessment, deteriorate,
or affect the participant's safety or ability to complete the study, including
hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,
immunologic, or hematologic disorders

- Significant systematic illness or infection in past 30 days

- Poor kidney function; estimated glomerular filtration rate (eGFR) <55

- Currently living in an institutional facility such as a nursing home

- Alcohol or substance abuse in past 1 year

- Changes in medications or doses of medication in past 3 months

- All allowed concomitant medications, supplements, or other substances must be at
stable doses for at least 3 months prior to screening, and must be kept as stable
as medically possible during the trial. If a change in medication dosage occurs
during the study, this will lead to discontinuation from study participation
unless it relates to a medication that, in the view of the study investigator,
does not affect participation in the trial.

- Use of prohibited medications/substances