NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial
Abstract Objective To investigate the efficacy and safety of MLC901 in vascular cognitive impairment no dementia (VCIND) patients. Design This was a multi‐center, double‐blind, randomized, placebo‐controlled pilot study. Setting and participant VCIND patients from hospitals in Singapore (67), Vietna...
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| Format: | Article |
| Language: | English |
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Wiley
2021-01-01
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| Series: | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/trc2.12161 |
| _version_ | 1817975383524376576 |
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| author | Christopher L. H. Chen Trọng Hung Nguyen Simeon Marasigan Chun Fan Lee Qingshu Lu Nagaendran Kandiah Deidre deSilva Eddie Chong Narayanaswamy Venketasubramanian |
| author_facet | Christopher L. H. Chen Trọng Hung Nguyen Simeon Marasigan Chun Fan Lee Qingshu Lu Nagaendran Kandiah Deidre deSilva Eddie Chong Narayanaswamy Venketasubramanian |
| author_sort | Christopher L. H. Chen |
| collection | DOAJ |
| description | Abstract Objective To investigate the efficacy and safety of MLC901 in vascular cognitive impairment no dementia (VCIND) patients. Design This 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. Methods The 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. Results The 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 [P = .05] and 9.9 seconds [P = .3] at week 12 and week 24, respectively). Conclusions Whilst 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. |
| first_indexed | 2024-04-13T21:48:13Z |
| format | Article |
| id | doaj.art-9f1467e8a4474ca582c5fc5840ecc544 |
| institution | Directory Open Access Journal |
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| language | English |
| last_indexed | 2024-04-13T21:48:13Z |
| publishDate | 2021-01-01 |
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| record_format | Article |
| series | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| spelling | doaj.art-9f1467e8a4474ca582c5fc5840ecc5442022-12-22T02:28:29ZengWileyAlzheimer’s & Dementia: Translational Research & Clinical Interventions2352-87372021-01-0171n/an/a10.1002/trc2.12161NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trialChristopher L. H. Chen0Trọng Hung Nguyen1Simeon Marasigan2Chun Fan Lee3Qingshu Lu4Nagaendran Kandiah5Deidre deSilva6Eddie Chong7Narayanaswamy Venketasubramanian8Memory and Aging Center Departments of Pharmacology and Psychological Medicine National University of Singapore SingaporeNeurology National Geriatric Hospital Hanoi VietnamNeurology and Psychiatry University of Santo Tomas Hospital Manila PhilippinesDuke‐NUS Centre for Quantitative Medicine Singapore Republic of SingaporeSingapore Clinical Research Institute Singapore Republic of SingaporeNeurology National Neurological Institute Singapore Republic of SingaporeNeurology Singapore General Hospital Singapore Republic of SingaporeMemory Aging and Cognition Center National University of Singapore Singapore Republic of SingaporeNeurology Raffles Neuroscience Centre Singapore Republic of SingaporeAbstract Objective To investigate the efficacy and safety of MLC901 in vascular cognitive impairment no dementia (VCIND) patients. Design This 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. Methods The 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. Results The 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 [P = .05] and 9.9 seconds [P = .3] at week 12 and week 24, respectively). Conclusions Whilst 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.https://doi.org/10.1002/trc2.12161clinical trialexecutive functionMLC901NEUROAID IIvascular cognitive impairment |
| spellingShingle | Christopher L. H. Chen Trọng Hung Nguyen Simeon Marasigan Chun Fan Lee Qingshu Lu Nagaendran Kandiah Deidre deSilva Eddie Chong Narayanaswamy Venketasubramanian NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial Alzheimer’s & Dementia: Translational Research & Clinical Interventions clinical trial executive function MLC901 NEUROAID II vascular cognitive impairment |
| title | NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial |
| title_full | NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial |
| title_fullStr | NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial |
| title_full_unstemmed | NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial |
| title_short | NEURoaid II (MLC901) in cognitively Impaired not demenTEd patientS (NEURITES): A pilot double blind, placebo‐controlled randomized trial |
| title_sort | neuroaid ii mlc901 in cognitively impaired not demented patients neurites a pilot double blind placebo controlled randomized trial |
| topic | clinical trial executive function MLC901 NEUROAID II vascular cognitive impairment |
| url | https://doi.org/10.1002/trc2.12161 |
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