NCT03601169

Comparison of MMFS Dosages in Older Adults

Comparison of MMFS Dosages for Improving Cognition, Mood, and Sleep Quality in Older Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Neurocentria, Inc. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Anxiety
• Depression
• Sleep Quality
• Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Dose MMFS-205-SR	Twice daily, oral 500mg tablets
DIETARY_SUPPLEMENT	High Dose MMFS-205-SR	Twice daily, oral 500mg tablets
DIETARY_SUPPLEMENT	Placebo	Twice daily, oral

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-07-26
• Last updated: 2020-09-09

Locations

1 site across 1 country: United States