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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
9
Twice daily, oral 500mg tablets
Twice daily, oral 500mg tablets
Twice daily, oral
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Neuropsychological Test Battery (NTB; computerized, at home, on-line) composite score
NTB consists of 5 cognitive tests, including: 1) N-Back Test for working memory; 2) Trail Making Test (TMT) assessing psychomotor processing speed and cognitive flexibility; 3) Backwards Digit Span Test for working memory; 4) Digit Symbol Substitution Test (DSST) measuring psychomotor processing speed; and 5) Block Tapping Test assessing visuo-spatial working memory. For each test, scores will be normalized using a z-score transformation. The mean of the 5 z-scores for each subject will be compared between low dose MMFS, high dose MMFs, and placebo groups. A score of 0 designates average performance. Each point above 0 designates 1 standard deviation above average and each point below 0 designates 1 standard deviation below average.
Time frame: 2 weeks each dose
Total Mood Disturbance (TMD) composite score measured by the Profile of Mood States - Brief Form (POMS-BF)
POMS-BF is a self-rated questionnaire on different moods over the past day. It consists of 30 questions pertaining to 6 domains of mood. Each question is rated on a 5-point scale (0-4). Lower scores indicate a better mood state. Comparison of the mean score between low dose MMFS, high dose MMFs, and placebo groups.
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Subjective Sleep Quality
Subjective measurements of daily anxiety by recording a daily diary (recorded in the morning) on a 10 point scale (1-10) with 1=Extremely poor and 10=Extremely good. Adapted from Consensus Sleep Diary.
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Refreshed Feeling
Subjective measurements of daily anxiety by recording a daily diary (recorded in the morning) on a 10 point scale (1-10) with 1=Extremely unrefreshed and 10=Extremely refreshed. Adapted from Consensus Sleep Diary.
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Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Anxiety
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely anxious and 10=Extremely relaxed. Adapted from Consensus Sleep Diary.
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Depression
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely depressed and 10=Extremely cheerful. Adapted from Consensus Sleep Diary.
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening- Subjective Cognitive Ability
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely poor and 10=Extremely good. Adapted from Consensus Sleep Diary.
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods