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This study is designed to compare the effectiveness of different doses of brain health supplement MMFS relative to placebo on cognition, mood, and sleep quality.
Full description
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).
Enrollment
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Volunteers
Inclusion criteria
Male or female subjects, aged 60 to 85 inclusive at the time of screening with informed consent.
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.
Subjects must have regular access to an internet-connected computer, iPad, tablet computer, and/or smart phone to complete online assessments.
Subjects with difficulty in maintaining sleep by the following criteria:
Insomnia Severity Index (ISI) score ≥ 10 and ≤ 21
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;
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)
Score of ≤ 7 and ≥ 4 on WMS-IV Logical Memory II (Delayed)
Subjects must be fluent in English
Subject must be willing to submit to blood draw(s).
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
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.
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)
Subject's residence is an institutional facility such as a nursing home.
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.
History or diagnosis of any of the following sleep conditions:
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.
Any of the following based on clinician interview :
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
History of alcoholism or drug dependency/abuse within the last 5 years of Screening, according to interview
Recent history (within the 6 months prior to Screening) of regular consumption (3 or more days per week) of either:
Known hypersensitivity to magnesium or to any of the formulation components (not including the common laxative effects of magnesium supplements)
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
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Primary purpose
Allocation
Interventional model
Masking
9 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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