A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II™ (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

开始日期2021-08-23

申办/合作机构

Moleac Pte Ltd.

NCT05621590

/ Completed早期临床1期IIT

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

In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months.
We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery

开始日期2020-03-10

申办/合作机构

Shahid Beheshti University of Medical Sciences

NCT03038035

/ Unknown status临床2期IIT

The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study : Assessing the Safety and Efficacy of Neuroaid II (MLC901) in Patients With Mild to Moderate Alzheimer's Disease Stable on Cholinesterase Inhibitors or Memantine: A Randomized, Double Blind, Placebo Controlled Trial

MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and neuroproliferative properties in cellular and animal models of brain injury. It contains 9 herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601, containing only the 9 herbal components yet showing the same efficacy has become available.
This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901) helps in slowing down the Alzheimer's disease progression.
This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by an open extension study in which all subjects who completed the main 6 month trial (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6 months.

开始日期2016-12-01

申办/合作机构

National University Hospital

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项与 MLC901 相关的文献（医药）

2024-04-01·Heliyon

Effects of Moleac 901 after severe spinal cord injury on chronic phase in Wistar rats

Article

作者: Islam, Andi Asadul ; Kamasan Nyoman Arijana, I Gusti ; Bagus Mahadewa, Tjokorda Gde ; Wiradewi Lestari, Anak Agung ; Maliawan, Sri ; Wiranata, Sinta ; Rosyidi, Rohadi Muhammad ; Wisnu Wardhana, Dewa Putu ; Jawi, I Made

Background:

MLC901 is a phytopharmaceutical comprising significant compounds that can induce microenvironments conducive to the proliferation and specialization of neural cell progenitors. This study investigates the impact of administering MLC901, reducing the expression of NG2 and caspase-3 and increasing IL-10 levels, as well as histopathological and motor function, after severe spinal cord injury (SCI) in the chronic phase.

Methods:

The study employed a randomized post-test-only control group design conducted between February and April 2023 at the Integrated Biomedical Laboratory. The participants in this study were categorized into three distinct groups: normal control, negative control, and therapy. A cohort of 18 rats was utilized for the study, with each group assigned a random allocation of six rats as subjects.

Results:

The findings demonstrated a statistically significant disparity in the average NG2 expression (-52.00 ± 20.03; p ≤ 0.05), as well as Caspase-3 expression (-94.89 ± 8.57; p ≤ 0.05), which exhibited a lower magnitude. The levels of IL-10 (8.96 ± 3.98; p ≤ 0.05) were observed to be higher, along with an elevation in BBB score (7.67 ± 0.89; p ≤ 0.05), which was more pronounced in the treatment group compared to the negative control group. The cut-off point for cavitation diameter is determined to be 114.915 μm, exhibiting a sensitivity and specificity of 100%. The area under curve (AUC) value is 1.0. The administration of MLC901 demonstrated a strong positive correlation with the increase in IL-10 levels (B 8.968; p ≤ 0.05), as well as a substantial negative correlation with the decrease in Caspase-3 expression (B -52.000; p ≤ 0.05) and NG2 expression (B -94.892; p ≤ 0.05). The administration of MLC901 via the upregulation of NG2 and Caspase-3 significantly increased the Basso, Beattie, and Bresnahan (BBB) scores.

Conclusions:

MLC901 positively affects motor and histopathological outcomes in the chronic phase of severe SCI in the Wistar rat model. These benefits are believed to be achieved by suppressing gliosis, neuroapoptosis, and neuroinflammation processes.

2023-11-01·Current aging science

A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study

作者: Tabatabaei, Fatemeh Sadat ; Amini Harandi, Ali ; Sobhanian, Seyed Ali ; Shirzadeh Barough, Siavash ; Esfandani, Akram ; Ilkhani, Saba ; Pakdaman, Hossein ; Siavoshi, Fatemeh ; Sharifipour, Ehsan ; Gharagozli, Koroush

Background::

MLC601 and MLC901 showed neuroprotective and neuroregenerative properties and positive results in the treatment of dementia and cognitive impairment. This study aimed to investigate the long-term benefits of monotherapy with MLC601 and MLC901 in patients with Alzheimer's disease (AD).

Methods::

In this study, patients with AD, diagnosed by DSM-IV criteria, were enrolled. Patients have received MLC601 for four years, and their regimen has changed to MLC901 for another four years. Recruited patients were followed to assess the efficacy and safety first of MLC601 and MLC901. Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) were used to assess cognitive function. Safety was evaluated by monitoring adverse events (AEs) and abnormal findings in physical examinations or lab tests.

Results::

At the end of the trial, the changes in the mean (±SD) MMSE and ADAS-Cog scores were 5.1 (3.09) and 12.5 (10.89), respectively. Both scores showed a significant change in repeated measure analysis, with the ADAS-Cog score indicating a higher change than the MMSE score (P < 0.001).

Conclusion::

For more than eight years, we studied monotherapy with NeuroAid (MLC601, MLC901) in patients with AD. The study contributes further to the long-term safety and efficacy data of MLC in patients with AD.

2023-10-01·Neurosurgery

Protocol for Safety and Efficacy of MLC901 (NeuroAiD II) in Patients With Moderate Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Trial (ANDROMEDA).

Article

作者: Yacapin, Vilma Jane ; Manalo, Guillermo L ; Ledesma, Lourdes K ; Chua, Annabell E

BACKGROUND AND OBJECTIVES:

Traumatic brain injury (TBI) remains a leading cause of death and disability, affecting approximately 69 million individuals each year worldwide. A significant portion of TBI research has focused on treatments for neuroprotection and/or neurorecovery, with most failing to transition to successful clinical applications despite promising animal/in vitro study results. MLC901 (NeuroAiD II), with origins from a traditional Chinese medicine, has been shown to exhibit both neuroprotective and neuroregenerative properties in in vitro and animal studies for stroke and TBI. Clinical trials have demonstrated its safety with significant improvements in some functional outcome and cognitive domain measures. The objective of this study is to determine the efficacy and safety of MLC901 (NeuroAiD II) vs placebo in adult patients with moderate TBI.

METHODS:

This is a multicenter randomized double-blind placebo-controlled trial that aims to enroll 120 adult patients with moderate TBI receiving standard of care in 2 arms: MLC901 vs placebo for a treatment period of 6 months with a further follow-up of 3 months. The total duration of the study is 9 months. The primary end point is Glasgow Outcome Scale Extended (GOS-E) at 6 months. Other assessments include mortality at 6 months, GOS-E, Glasgow Coma Scale, Montreal Cognitive Assessment Filipino Version, Frontal Assessment Battery Conflicting Instructions and Go-No-Go, Rivermead Post-Concussion Symptom Questionnaire, Barthel Index, Hospital Anxiety and Depression Scale, and Health related Quality of life (EQ-5D) at 1, 3, 6, and 9 months. Cerebral swelling at baseline and at 1 and 2 weeks will also be documented. Adverse events and drug compliance will also be monitored.

EXPECTED OUTCOMES:

We expect to find a significant improvement in functional and cognitive outcomes in patients who were given MLC901.

DISCUSSION:

Previous studies on the effect of MLC901 in adult patients with moderate TBI showed positive results; However, these studies are limited by the small number of patients. This study will establish a more definitive role of MLC901 in improving functional and cognitive outcomes in patients with moderate TBI.

项与 MLC901 相关的新闻（医药）

2024-10-21

·PRNewswire

Moleac Announces PT Ferron Par Pharmaceuticals as New Exclusive Partner in Indonesia

SINGAPORE, Oct. 21, 2024 /PRNewswire/ -- Moleac is excited to announce a significant milestone in the journey of NeuroAiD II MLC901 as PT Ferron Par Pharmaceuticals will become our exclusive partner in Indonesia effective Jan 1st 2025. We are immensely grateful for the fruitful 12-year partnership with PT Mersifarma Tirmaku Mercusana, and we sincerely thank them for their invaluable contributions to our success in Indonesia. As we embark on a new chapter, we are thrilled to welcome PT Ferron Par Pharmaceuticals — a member of Dexa Group — as our new exclusive commercial partner. This partnership marks a crucial milestone in our mission to widen access to our groundbreaking products, supporting healthcare professionals in enhancing outcomes for patients recovering from stroke, traumatic brain injuries, and neurodegenerative diseases. With PT Ferron Par Pharmaceuticals, a leader renowned for its market expertise and operational excellence, we are confident in our accelerated growth and the expanded availability of NeuroAiD II MLC901 to those in need. We look forward to a future of growth and continued innovation as we extend the reach of NeuroAiD II MLC901 in Indonesia to benefit more patients. About Moleac Moleac is a biopharmaceutical company that stays committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering a loss of brain function after brain injuries or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. For further information, visit moleac.com. About PT Ferron Par Pharmaceuticals PT Ferron Par Pharmaceuticals, a member of Dexa Group, is a fast growing pharmaceutical company that started its operation in 2001. Ferron has become one of the 20 largest pharmaceutical operations in Indonesia (Combined IHPA+IPA 2005, IMS Audit). With a diverse product portfolio, advanced manufacturing capabilities, and strong partnerships, Ferron continues to strengthen its market presence and operational excellence. For more information, visit dexagroup.com. SOURCE Moleac WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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2022-06-06

·PRNewswire

NeuroAiD has shown favourable outcome in patients suffering from spinal cord injuries

SATURN study aimed at assessing the safety and effects of a 6-month course of NeuroAiD (MLC601/MLC901) to augment functional and motor recovery after severe spinal cord injury (SCI). NeuroAiD was safe as add-on treatment in patients with severe SCI. One third of patients improved on ASIA Impairment Scale (AIS) grading with corresponding motor recovery at month 6. SINGAPORE, June 6, 2022 /PRNewswire/ -- Moleac is pleased to announce the release of the results of the SATURN study1 published online in the Journal of Spinal Cord Medicine . Spinal cord injury (SCI) carries debilitating consequences with severe neurological and functional deficits, deteriorating the quality of life for survivors and their relatives. To date, there is no way to reverse spinal cord damage, and new treatments are always sought, including prostheses, devices and medications, to improve motor function and function recovery in SCI. NeuroAiD has well established neuroprotective and neurorepair properties that enhance neurological recovery on top of rehabilitation in stroke and traumatic brain injury. It could represent a new therapeutic approach for SCI patients. SATURN (Spinal cord injury Assessing Tolerability and Use of combined Rehabilitation and NeuroAiD) study was designed to evaluate the safety and potential role of NeuroAiD in subjects suffering from severe SCI. This pilot study included 30 subjects with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A and B, who received a 6-month course of NeuroAiD on top of standard care and rehabilitation. The key endpoints were the safety profile by measuring the occurrence of adverse events (AEs) during the 6-month course of NeuroAiD and the improvements in the AIS grade and motor score at month 6. Key findings: A total of 14 AEs were reported by 10 patients, none being deemed definitely, likely or possibly related to NeuroAiD. 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. One patient has even achieved complete recovery (grade E). The Asia total motor score improved over time from 17.1 at baseline to 49.9 at month 6. Of note, the investigators pointed out that the improvement rates during the 6-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A. "Any improvement in AIS grading is clinically important for SCI patients," said Prof. Ramesh Kumar, neurosurgeon at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. "The rates of improvement we saw at 6 months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option." NeuroAiD shows a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries. ACCESS THE ARTICLE HERE About NeuroAiD NeuroAiD is a 9 component-herbal supplements that is carries the neuroprotective and neurorestorative properties. Multiple clinical studies were conducted in NeuroAiD showing efficacy in stroke, and patients with traumatic brain injuries. About Moleac Moleac is a biopharmaceutical company committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering from a loss of brain functions after a brain injury or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine, establish their clinical properties, and make them available internationally. NeuroAiDTM and NurAiDTM are trademarks of Moleac. MLC601 (NeuroAiDTM) and MLC901 (NeuroAiDTMII/NurAiDTMII) are two different proprietary formulae which have been shown to be equivalent in pharmacology and are referred as "NeuroAiD" in this document. Ramesh Kumar et al. Spinal cord injury – assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study – primary results of an exploratory study. The Journal of Spinal Cord Medicine. May 2022, DOI: 10.1080/10790268.2022.2067972. For more information, contact [email protected] SOURCE Moleac

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脑梗塞	临床2期	新加坡	Moleac Pte Ltd.	2008-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03038035 (ATHENE, CTAD2022)	临床2期	阿尔茨海默症追加	125	MLC901 (NeuroAiD-II)	憲繭築憲壓簾衊膚網遞(襯網鏇鏇鑰廠窪蓋蓋獵) = 築觸襯鹽鬱糧憲繭鹽艱醖衊繭鹹衊艱壓獵築糧 (積願鏇鬱鏇襯憲艱顧繭, -6.06 ~ -1.28)	积极	2022-12-03
				Placebo	-