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J Alzheimers Dis. 2016;49(4):971-90. doi: 10.3233/JAD-150538.

Efficacy and Safety of MMFS-01, a Synapse Density Enhancer, for Treating Cognitive Impairment in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.

Author information

  • 1Neurocentria, Inc., Fremont, CA, USA.
  • 2School of Medicine, Tsinghua University, Beijing, China.
  • 3Department of Psychology, The Ohio State University, Columbus, OH, USA.
  • 4Department of Psychology, University of Southern California, Los Angeles, CA, USA.

Abstract

BACKGROUND:

Cognitive impairment is a major problem in elderly, affecting quality of life. Pre-clinical studies show that MMFS-01, a synapse density enhancer, is effective at reversing cognitive decline in aging rodents.

OBJECTIVE:

Since brain atrophy during aging is strongly associated with both cognitive decline and sleep disorder, we evaluated the efficacy of MMFS-01 in its ability to reverse cognitive impairment and improve sleep.

METHODS:

We conducted a randomized, double-blind, placebo-controlled, parallel-designed trial in older adult subjects (age 50-70) with cognitive impairment. Subjects were treated with MMFS-01 (n = 23) or placebo (n = 21) for 12 weeks and cognitive ability, sleep quality, and emotion were evaluated. Overall cognitive ability was determined by a composite score of tests in four major cognitive domains.

RESULTS:

With MMFS-01 treatment, overall cognitive ability improved significantly relative to placebo (p = 0.003; Cohen's d = 0.91). Cognitive fluctuation was also reduced. The study population had more severe executive function deficits than age-matched controls from normative data and MMFS-01 treatment nearly restored their impaired executive function, demonstrating that MMFS-01 may be clinically significant. Due to the strong placebo effects on sleep and anxiety, the effects of MMFS-01 on sleep and anxiety could not be determined.

CONCLUSIONS:

The current study demonstrates the potential of MMFS-01 for treating cognitive impairment in older adults.

KEYWORDS:

Alzheimer’s disease; L-threonate; cognition; cognitive impairment; composite score; magnesium; mild cognitive impairment; randomized clinical trial; sleep disorder; synaptic density

PMID:
26519439
PMCID:
PMC4927823
DOI:
10.3233/JAD-150538
[PubMed - indexed for MEDLINE]
Free PMC Article
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