Evidence map›Paper›PMID 33816765›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2021

NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo-controlled randomized trial.

Christopher L H Chen, Trọng Hung Nguyen, Simeon Marasigan, Chun Fan Lee, Qingshu Lu, Nagaendran Kandiah, Deidre de Silva, Eddie Chong, Narayanaswamy Venketasubramanian

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 26% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. 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

9 authors at 8 institutions in 3 countries.

Christopher L H ChenMemory and Aging Center Departments of Pharmacology and Psychological Medicine National University of Singapore Singapore.
Trọng Hung NguyenNeurology National Geriatric Hospital Hanoi Vietnam.
Simeon MarasiganNeurology and Psychiatry University of Santo Tomas Hospital Manila Philippines.
Chun Fan LeeDuke-NUS Centre for Quantitative Medicine Singapore Republic of Singapore.
Qingshu LuSingapore Clinical Research Institute Singapore Republic of Singapore.
Nagaendran KandiahNeurology National Neurological Institute Singapore Republic of Singapore.
Deidre de SilvaNeurology Singapore General Hospital Singapore Republic of Singapore.
Eddie ChongMemory Aging and Cognition Center National University of Singapore Singapore Republic of Singapore.
Narayanaswamy VenketasubramanianNeurology Raffles Neuroscience Centre Singapore Republic of Singapore.
National University of Singapore · SGDuke-NUS Medical School · SGNational Hospital of Pediatrics · VNNational Neuroscience Institute · SGRaffles Institution · SGSingapore Clinical Research Institute · SGSingapore General Hospital · SGUniversity of Santo Tomas Hospital · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of MLC901 in vascular cognitive impairment no dementia (VCIND) patients.

designThis was a multi-center, double-blind, randomized, placebo-controlled pilot study. SETTING AND PARTICIPANT: VCIND patients from hospitals in Singapore (67), Vietnam (19), and the Philippines (17) were recruited and followed-up from March 2013 to April 2018.

methodsThe primary outcome was executive function as measured by the Verbal Fluency (VF) and 2-part Color Trails Test (CTT). The mean difference in the scores between baseline and week 12, and baseline and week 24, was compared between MLC901 and placebo using a two-sample t-test.

resultsThe trial randomized 103 subjects: MLC901 (n = 57) and placebo (n = 46). The mean age of participants was 68.3 ± 8.4 years and 38.8% were female. Improvement in executive function with MLC901 was not significantly better than placebo at week 12 (CTT1 mean difference [md] 3.8 seconds, 95% confidence interval [CI]: -9.0 to 16.5, CTT2 md 10.9 seconds, 95% CI: -0.2 to 22.0), and at week 24 (CTT1 md 2.8 seconds, 95% CI: -8.4 to 14.0, CTT2 md = 4.4 seconds, 95% CI: -8.2 to 16.9). Improvement in VF from baseline was not significantly different between MLC901 and placebo at weeks 12 and 24. There were no significant differences in adverse events (43.5% vs. 56.1%) or serious adverse events (13% vs. 22.8%) in placebo versus MLC901 groups. In post hoc exploratory analysis, the treatment effect of MLC901 on cognitive function appears more apparent in subjects with existing impairment in executive function: CTT2 (md 14.4 seconds [

conclusionsWhilst MLC901 appears to be safe, there was no significant cognitive benefit from MLC901 in the study population. Post hoc hypotheses generating analyses suggest that VCIND patients with existing impairment in executive function may show benefit.

Indexed as

clinical trialexecutive functionMLC901NEUROAID IIvascular cognitive impairment

Identifiers

PMID33816765
PMCPMC8010368
OpenAlexW3140699632

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.