Comparison of MMFS Dosages in Older Adults

This is a phase 2 study in older adults with at least mild progressive behavioral symptoms,
subjective sleep maintenance problems, and at least mild progressive cognitive deficit. The
study is a randomized, double-blind, placebo-controlled, three-way crossover design, in which
participants will receive oral placebo, low dose MMFS, and high dose MMFS twice daily for 6
weeks. Over three study periods (2 weeks each), subjects will receive two different dosages
of MMFS (low dose: ~22.5 mg/kg LBM/day and high dose: ~35 mg/kg LBM/day) and placebo. After
periods 1 and 2 there will be a one week washout period in which the subject will not take
any study tablets. Randomized patients and their informants (required) will complete 5
assessments total: at baseline in the clinic (visit 1; prior to taking any study tablets),
and 4 times at home via online assessments (at the beginning of period 1 and at the end of
periods 1, 2, and 3. The effectiveness of different MMFS dosages on cognition, mood, and
sleep quality will be assessed using a Neuropsychological Test Battery, Profile of Mood
States-Brief Form, daily sleep diaries, and Insomnia Severity Index. The safety profile of
different MMFS dosages will be determined by monitoring the AE/SAE and subjective remarks
during the study period. A range of safety and tolerability assessments will also be
performed (including vital signs and laboratory tests).

Inclusion Criteria:

1. Male or female subjects, aged 60 to 85 inclusive at the time of screening with
informed consent.

2. Subjects with body weight within 50 to 125 kg and height within 152.4 to 198.12 cm,
able to comply with study requirements; have received high school diploma, GED, or
equivalent.

3. Subjects must have regular access to an internet-connected computer, iPad, tablet
computer, and/or smart phone to complete online assessments.

4. Subjects with difficulty in maintaining sleep by the following criteria:

- Insomnia Severity Index (ISI) score ≥ 10 and ≤ 21

- 2 (moderate) or greater on question 2 OR question 3 of ISI

5. Subjects with at least "moderate" neuropsychiatric symptoms, as determined by a score
of 6 or higher on the Mild Behavioral Impairment - Checklist (MBI-C) informant-report
scale;

- Subjective report of worsened neuropsychiatric symptoms (e.g., MBI-C items such
as motivation, depression, anxiety, impulse control, delusions) since age 50,
with recent decline

6. Score ≤ 7 and ≥ 4 on the D-KEFS Trail Making Test Condition 4 - letter-number
switching test of executive function at screening, controlled for motor speed
(condition 5)

- Subjective report of worsened memory since age 50, with recent decline

7. Score of ≤ 7 and ≥ 4 on WMS-IV Logical Memory II (Delayed)

8. Subjects must be fluent in English

9. Subject must be willing to submit to blood draw(s).

10. Subjects must be able to understand the study, agree to the requirements and
restrictions, be able to attend all scheduled visits, and be willing to give voluntary
consent to participate in the study.

Exclusion Criteria:

1. Subject with insomnia due to bladder problems, or other confounding medical condition
such as chronic pain syndromes, chronic migraine, cardiac disease, nocturia (> 3
times/night), asthma, gastroesophageal reflux disease (GERD), or hot flashes,
determined by investigators.

2. Subject diagnosed with severe sleep apnea that is not treated/well-managed (e.g., by
regular use of Continuous Positive Airway Pressure, CPAP, or Bilevel Positive Airway
Pressure, BIPAP, device)

3. Subject's residence is an institutional facility such as a nursing home.

4. Females of child-bearing potential as defined as status post onset of menarche and not
meeting any of the following conditions: menopausal for at least 2 years, status after
bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or
status after hysterectomy.

5. History or diagnosis of any of the following sleep conditions:

- Narcolepsy

- Cataplexy (familial or idiopathic)

- Circadian Rhythm Sleep Disorder

- Primary Hypersomnia

6. Subjects with history or presence of any clinically significant cardiovascular
(myocardial infarction; coronary angioplasty or bypass graft(s); valvular disease or
repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular
accidents (CVA); congestive heart failure or coronary artery disease (CAD), clinically
important carotid or vertebrobasilar stenosis or plaque, pulmonary, respiratory,
hepatic, renal (including poor kidney function, eGFR <55 mL/min), hematological
(sickle cell anemia or thalassemia, sideroblastic anemia or anemia of any etiology),
gastrointestinal, endocrine (diabetes type I or II), immunologic, dermatologic,
neurological, psychiatric disease or disorder within 6 months, or any uncontrolled
medical illness which in the opinion of the Investigator would jeopardize the safety
of the subject.

Nonetheless, subjects with controlled co-morbid conditions (including diabetes,
hypertension, heart disease, etc.) are permitted if considered stable within three
months of the study start. All 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.

7. Any of the following based on clinician interview :

1. Clinically significant psychiatric illness in past 6 months requiring
hospitalization

2. Other psychiatric condition that, in the investigator's opinion, would interfere
with the subject's ability to participate in the study

8. Suicidal ideation with intent, with or without a plan or method in the past 1 month or
suicidal behavior in the past 6 months of Screening

9. History of alcoholism or drug dependency/abuse within the last 5 years of Screening,
according to interview

10. Recent history (within the 6 months prior to Screening) of regular consumption (3 or
more days per week) of either:

1. 2 or more (women) or 3 or more (men) alcoholic beverages per day or alcohol
consumption within 3 hours prior to bedtime

2. More than 600 mg caffeine a day (e.g., 4 standard 8-ounce cups of brewed coffee,
or typically consumes caffeine after 4pm [16:00])

11. Known hypersensitivity to magnesium or to any of the formulation components (not
including the common laxative effects of magnesium supplements)

12. Currently participating or has participated in a study with an investigational
compound or device within 30 days of signing informed consent, or intent to
participate in another clinical trial at any time during the conduct of this trial

13. Any other clinical condition that, in the opinion of the investigator, might pose
additional risk to the subject due to participation in the study.