Comparison of MMFS Dosages in Older Adults

NCT03601169 | Completed Phase 2

• 1 other identifier: NC010
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression; Sleep Quality; Cognitive Impairment

Keywords

cognition; mood; sleep

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks each dose

Secondary Outcomes (6)

• Total Mood Disturbance (TMD) composite score measured by the Profile of Mood States - Brief Form (POMS-BF)

  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

  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

  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

  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

  2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods

Other Outcomes (1)

• Insomnia Severity Index (ISI) score

  2 weeks each dose

Study Arms (3)

Low Dose MMFS-205-SR

EXPERIMENTAL

Low dose, oral MMFS-205-SR twice daily (1,000 or 1,500 mg/day total, depending on lean body mass: \~22mg/kg LBM/day) for 6 weeks

Dietary Supplement: Low Dose MMFS-205-SR

High Dose MMFS-205-SR

EXPERIMENTAL

High dose, oral MMFS-205-SR twice daily (1,500 or 2,000 mg/day total, depending on lean body mass: \~33mg/kg LBM/day) for 6 weeks

Dietary Supplement: High Dose MMFS-205-SR

Placebo

PLACEBO COMPARATOR

Oral inactive placebo twice daily for 6 weeks

Dietary Supplement: Placebo

Interventions

Low Dose MMFS-205-SR DIETARY_SUPPLEMENT

Twice daily, oral 500mg tablets

Also known as: L-threonic acid magnesium salt, L-TAMS

Low Dose MMFS-205-SR

High Dose MMFS-205-SR DIETARY_SUPPLEMENT

Twice daily, oral 500mg tablets

Also known as: L-threonic acid magnesium salt, L-TAMS

High Dose MMFS-205-SR

Placebo DIETARY_SUPPLEMENT

Twice daily, oral

Also known as: inactive sugar pill

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Narcolepsy
• Cataplexy (familial or idiopathic)
• Circadian Rhythm Sleep Disorder
• Primary Hypersomnia
• 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 :
• Clinically significant psychiatric illness in past 6 months requiring hospitalization
• Other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the study
• 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

Sponsors & Collaborators

• Neurocentria, Inc.: lead

Study Sites (1)

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Interventions

threonic acid

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Donald Burkindine, MD

  Bio-Kinetic Clinical Applications, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 26, 2018
• Study Start: July 23, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)