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MLC601 in vascular dementia: an efficacy and safety pilot study

Authors Pakdaman H, Amini Harandi A, Gharagozli K, Abbasi M, Ghaffarpour M, Ashrafi F, Delavar Kasmaei H, Amini Harandi A

Received 28 June 2017

Accepted for publication 31 August 2017

Published 5 October 2017 Volume 2017:13 Pages 2551—2557

DOI https://doi.org/10.2147/NDT.S145047

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Prof. Dr. Roumen Kirov

Peer reviewer comments 2

Editor who approved publication: Dr Roger Pinder


Hossein Pakdaman,1 Ali Amini Harandi,1 Koroush Gharagozli,1 Mehdi Abbasi,1 Majid Ghaffarpour,2 Farzad Ashrafi,1 Hosein Delavar Kasmaei,1 Asghar Amini Harandi3

1Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; 2Iranian Center of Neurological Research, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran; 3Department of Biochemistry, School of Medicine, Jiroft University of Medical Sciences, Jiroft, Iran

Background and aim:
Vascular dementia (VaD) is the second most common cause of dementia and currently there is scarcity of therapies for VaD. We aimed to investigate the efficacy and safety of MLC601 in the treatment of VaD.
Methods: In this multicenter, pilot, randomized, double-blind trial, 82 patients with VaD according to DSM-5 criteria received MLC601 or placebo capsules three times a day for 2 years. The primary efficacy end-point was evaluated by comparing Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) score between the two groups over 2 years of study. Safety was also assessed by recording adverse events and abnormal laboratory results.
Results: Eighty-one patients completed the study and were included in the analysis. One patient was lost to follow-up in the placebo group. After 2 years, mean (±SD) changes in the MMSE score were –3.71 (±4.50) for MLC601 group and –9.33 (±4.80) for placebo group. ADAS-cog score showed (±SD) changes of 7.34 (±9.55) and 19.00 (±11.28) for MLC601 and placebo group, respectively. Repeated measures analyses showed that both MMSE and ADAS-cog scores were significantly better in the treatment group at 24 months (p<0.001). Ten (24.39%) patients reported predominantly transient gastrointestinal adverse events in MLC601 group. No patient left the study due to adverse events. There were no clinically significant abnormalities on laboratory tests.
Conclusion:
Patients treated with MLC601 over the 2 years showed dramatically better cognitive outcome compared with those treated with placebo. MLC601 was devoid of any serious adverse events and was well-tolerated.

Keywords: vascular dementia, MLC601, safety, randomized placebo-controlled trial

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