Evidence map›Paper›PMID 29042785›Full record

ArticleNeuropsychiatric disease and treatment2017

MLC601 in vascular dementia: an efficacy and safety pilot study.

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

Registry-linked trialAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05621590 (MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05621590 early_phase1completednot on this mapstarted 2020, after this paper: background citation

MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

TypeinterventionalSponsorShahid Beheshti University of Medical SciencesRan2020 to 2022Enrolled35ConditionsHypoxic Ischaemic Encephalopathy Due to Cardiac ArrestArmsMLC 901, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Hossein PakdamanBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Ali Amini HarandiBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Koroush GharagozliBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mehdi AbbasiBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Majid GhaffarpourIranian Center of Neurological Research, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Farzad AshrafiBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hosein Delavar KasmaeiBrain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Asghar Amini HarandiDepartment of Biochemistry, School of Medicine, Jiroft University of Medical Sciences, Jiroft, Iran.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimVascular 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.

methodsIn 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.

resultsEighty-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 (

conclusionPatients 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.

Indexed as

MLC601randomized placebo-controlled trialsafetyvascular dementia

Identifiers

PMID29042785
PMCPMC5634376

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.