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Effectiveness and Safety of Mlc601 in the Treatment of Mild to Moderate Alzheimer's Disease: A Multicenter, Randomized Controlled Trial Publisher



Pakdaman H1 ; Harandi AA1 ; Hatamian H3 ; Tabatabae M2 ; Kasmaei HD1 ; Ghassemi A4 ; Gharagozli K1 ; Ashrafi F1 ; Naeini PE5 ; Tavakolian M1 ; Shahin D1
Authors
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Authors Affiliations
  1. 1. Department of Neurology, Shahid Beheshti University of Medical Sciences, Velenjak Street, Tehran, 4739, Iran
  2. 2. Social Security, Tehran, Iran
  3. 3. Department of Neurology, Rasht University of Medical Sciences, Rasht, Iran
  4. 4. Social Security, Kerman, Iran
  5. 5. School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

Source: Dementia and Geriatric Cognitive Disorders Extra Published:2015


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). Conclusion: MLC601 showed a promising safety profile and also efficacy compared to 3 FDA-approved ChEIs. © 2015 S. Karger AG, Basel.
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