PMID- 29805383
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 1664-5464 (Print)
IS  - 1664-5464 (Electronic)
IS  - 1664-5464 (Linking)
VI  - 8
IP  - 1
DP  - 2018 Jan-Apr
TI  - Efficacy and Safety of MLC601 in Patients with Mild to Moderate Alzheimer 
      Disease: An Extension 4-Year Follow-Up Study.
PG  - 174-179
LID - 10.1159/000488482 [doi]
AB  - BACKGROUND AND AIM: Alzheimer disease (AD) is the most common cause of dementia. 
      Currently, there is no disease-modifying therapy for AD. We aimed to evaluate the 
      long-term efficacy and safety of MLC601 in the treatment of AD. METHODS: In this 
      open-label extension study, patients with mild to moderate AD according to DSM-IV 
      criteria were recruited. Patients received MLC601 capsules 3 times a day for 4 
      years. Cognitive function was assessed every 6 months using Mini-Mental State 
      Examination (MMSE) and Alzheimer's Disease Assessment Scale-Cognitive Subscale 
      (ADAS-Cog) scores. Safety profiles, including adverse events (AEs), and 
      treatment-related abnormality in laboratory tests were also reported. RESULTS: Of 
      a total of 122 patients, 105 completed the study. The mean age was 66.8 +/- 6.3 
      years at the beginning of the study. Sixty-five (61.9%) were female. The mean 
      (+/-SD) change in MMSE and ADAS-Cog scores at the end of the study was 2.1 (+/-3.8) 
      and -5.1 (+/-8.7), respectively. Repeated measure analysis revealed a statistically 
      significant change in both scores (p < 0.001). No patient left the study due to 
      an AE. No abnormality was noted in lab tests. Gastrointestinal symptoms were the 
      most commonly reported AEs. CONCLUSION: The efficacy of treating AD patients with 
      MLC601 over 4 years has been demonstrated in the present study. Overall, it seems 
      that the safety and efficacy of MLC601 is promising compared to currently 
      prescribed treatments.
FAU - Pakdaman, Hossein
AU  - Pakdaman H
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 - Abbasi, Mehdi
AU  - Abbasi M
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Sobhanian, Ali
AU  - Sobhanian A
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Bakhshandehpour, Ali
AU  - Bakhshandehpour A
AD  - Health and Human Physiology School, University of Iowa, Iowa City, Iowa, USA.
FAU - Ashrafi, Farzad
AU  - Ashrafi F
AD  - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, 
      Tehran, Iran.
FAU - Khalilzad, Mitra
AU  - Khalilzad M
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.
LA  - eng
PT  - Journal Article
DEP - 20180426
PL  - Switzerland
TA  - Dement Geriatr Cogn Dis Extra
JT  - Dementia and geriatric cognitive disorders extra
JID - 101564825
PMC - PMC5968230
OTO - NOTNLM
OT  - Alzheimer disease
OT  - Follow-up study
OT  - MLC601
OT  - Safety
EDAT- 2018/05/29 06:00
MHDA- 2018/05/29 06:01
PMCR- 2018/04/26
CRDT- 2018/05/29 06:00
PHST- 2018/01/08 00:00 [received]
PHST- 2018/03/12 00:00 [accepted]
PHST- 2018/05/29 06:00 [entrez]
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2018/05/29 06:01 [medline]
PHST- 2018/04/26 00:00 [pmc-release]
AID - dee-0008-0174 [pii]
AID - 10.1159/000488482 [doi]
PST - epublish
SO  - Dement Geriatr Cogn Dis Extra. 2018 Apr 26;8(1):174-179. doi: 10.1159/000488482. 
      eCollection 2018 Jan-Apr.