title: Effectiveness and Safety of MLC601 in the Treatment of Mild to Moderate Alzheimer's Disease: A Multicenter, Randomized Controlled Trial.
abstract: BACKGROUND
  MLC601 is a possible modulator of amyloid precursor protein processing, and in a clinical trial study MLC601 showed some effectiveness in cognitive function in Alzheimer's disease (AD) patients. We aimed to evaluate the effectiveness and safety of MLC601 in the treatment of mild to moderate AD as compared to 3 approved cholinesterase inhibitors (ChEIs) including donepezil, rivastigmine and galantamine.
  
  
  METHODS
  In a multicenter, nonblinded, randomized controlled trial, 264 volunteers with AD were randomly divided into 4 groups of 66; groups 1, 2, 3 and 4 received donepezil, rivastigmine, MLC601 and galantamine, respectively. Subjects underwent a clinical diagnostic interview and a cognitive/functional battery including the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). Patients were visited every 4 months, and the score of cognition was recorded by the neurologists.
  
  
  RESULTS
  There were no significant differences in age, sex, marital status and baseline score of cognition among the 4 groups. In total, 39 patients (14.7%) left the study. Trend of cognition changes based on the modifications over the time for MMSE and ADAS-cog scores did not differ significantly among groups (p = 0.92 for MMSE and p = 0.87 for ADAS-Cog).
  
  
  CONCLUSIONS
  MLC601 showed a promising safety profile and also efficacy compared to 3 FDA-approved ChEIs.
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Hossein
authors: H
authors: Pakdaman
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Ali Amini
authors: AA
authors: Harandi
authors: Department of Neurology, Rasht University of Medical Sciences, Rasht, Iran.
authors: Hamidreza
authors: H
authors: Hatamian
authors: Social Security, Tehran, Rasht University of Medical Sciences, Rasht, Iran.
authors: Mojgan
authors: M
authors: Tabatabae
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Hosein
authors: H
authors: Delavar Kasmaei
authors: Social Security, Kerman, Isfahan University of Medical Sciences, Isfahan, Iran.
authors: Amirhossein
authors: A
authors: Ghassemi
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Koroush
authors: K
authors: Gharagozli
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Farzad
authors: F
authors: Ashrafi
authors: School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
authors: Pardis
authors: P
authors: Emami Naeini
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Mehrnaz
authors: M
authors: Tavakolian
authors: Department of Neurology, Shahid Beheshti University of Medical Sciences, Iran.
authors: Darush
authors: D
authors: Shahin
keywords: Alzheimer's disease; Cholinesterase inhibitor; Donepezil; Efficacy; Galantamine; MLC601; Rivastigmine; Safety