PMID- 28626468
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 1664-5464 (Print)
IS  - 1664-5464 (Electronic)
IS  - 1664-5464 (Linking)
VI  - 7
IP  - 1
DP  - 2017 Jan-Apr
TI  - Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A 
      Pilot, Randomized, Double-Blind, Placebo-Controlled Study.
PG  - 136-142
LID - 10.1159/000458521 [doi]
AB  - BACKGROUND AND AIM: Mild cognitive impairment (MCI) is characterized by declined 
      cognitive function greater than that expected for a person's age. The clinical 
      significance of this condition is its possible progression to dementia. MLC601 is 
      a natural neuroprotective medication that has shown promising effects in 
      Alzheimer disease. Accordingly, we conducted this randomized, double-blind, 
      placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI 
      patients. METHODS: Seventy-two patients with a diagnosis of MCI were recruited. 
      The included participants were randomly assigned to groups to receive either 
      MLC601 or placebo. An evaluation of global cognitive function was performed at 
      baseline as well as at 3-month and 6-month follow-up visits. Global cognitive 
      function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer's 
      Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was 
      evaluated by comparing global function scores between the 2 groups during the 
      study period. Safety assessment included adverse events (AEs) and abnormal 
      laboratory results. RESULTS: Seventy patients completed the study, 34 in the 
      MLC601 group and 36 in the placebo group. The mean changes (+/-SD) in cognition 
      scores over 6 months in the MLC601 group were -2.26 (+/-3.42) for the MMSE and 3.82 
      (+/-6.16) for the ADAS-cog; in the placebo group, they were -2.66 (+/-3.43) for the 
      MMSE and 4.41 (+/-6.66) for the ADAS-cog. The cognition changes based on both MMSE 
      and ADAS-cog scores were statistically significant between the placebo and the 
      MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the 
      MLC601 group, the most commonly reported of which were gastrointestinal, none of 
      them leading to patient withdrawal. CONCLUSION: MLC601 has shown promising 
      efficacy and acceptable AEs in MCI patients.
FAU - Pakdaman, Hossein
AU  - Pakdaman H
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Amini Harandi, Ali
AU  - Amini Harandi A
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Abbasi, Mehdi
AU  - Abbasi M
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Delavar Kasmaei, Hosein
AU  - Delavar Kasmaei H
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Ashrafi, Farzad
AU  - Ashrafi F
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Gharagozli, Koroush
AU  - Gharagozli K
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Assarzadegan, Farhad
AU  - Assarzadegan F
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Behnam, Behdad
AU  - Behnam B
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Arabahmadi, Mehran
AU  - Arabahmadi M
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
LA  - eng
PT  - Journal Article
DEP - 20170504
PL  - Switzerland
TA  - Dement Geriatr Cogn Dis Extra
JT  - Dementia and geriatric cognitive disorders extra
JID - 101564825
PMC - PMC5471755
OTO - NOTNLM
OT  - Double-blind study
OT  - MLC601
OT  - Mild cognitive impairment
OT  - Placebo-controlled study
OT  - Safety
EDAT- 2017/06/20 06:00
MHDA- 2017/06/20 06:01
PMCR- 2017/05/04
CRDT- 2017/06/20 06:00
PHST- 2016/11/07 00:00 [received]
PHST- 2017/01/30 00:00 [accepted]
PHST- 2017/06/20 06:00 [entrez]
PHST- 2017/06/20 06:00 [pubmed]
PHST- 2017/06/20 06:01 [medline]
PHST- 2017/05/04 00:00 [pmc-release]
AID - dee-0007-0136 [pii]
AID - 10.1159/000458521 [doi]
PST - epublish
SO  - Dement Geriatr Cogn Dis Extra. 2017 May 4;7(1):136-142. doi: 10.1159/000458521. 
      eCollection 2017 Jan-Apr.