title: Efficacy and Safety of MMFS-01, a Synapse Density Enhancer, for Treating Cognitive Impairment in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.
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.
authors.affiliation: Neurocentria, Inc., Fremont, CA, USA.|School of Medicine, Tsinghua University, Beijing, China.
authors.forename: Guosong
authors.initials: G
authors.lastname: Liu
authors.affiliation: Neurocentria, Inc., Fremont, CA, USA.
authors.forename: Jason G
authors.initials: JG
authors.lastname: Weinger
authors.affiliation: Department of Psychology, The Ohio State University, Columbus, OH, USA.
authors.forename: Zhong-Lin
authors.initials: ZL
authors.lastname: Lu
authors.affiliation: Department of Psychology, University of Southern California, Los Angeles, CA, USA.
authors.forename: Feng
authors.initials: F
authors.lastname: Xue
authors.affiliation: Neurocentria, Inc., Fremont, CA, USA.
authors.forename: Safa
authors.initials: S
authors.lastname: Sadeghpour
mesh_terms: D000368:Aged; D001007:Anxiety / Q000188:drug therapy; D002087:Butyrates / Q000009:adverse effects / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D004644:Emotions / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D012890:Sleep / Q000187:drug effects; D013569:Synapses / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D002087:Butyrates; D018697:Nootropic Agents; C011369:threonic acid
keywords: Alzheimer’s disease; L-threonate; cognition; cognitive impairment; composite score; magnesium; mild cognitive impairment; randomized clinical trial; sleep disorder; synaptic density