Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

Pakdaman, Hossein; Harandi, Ali Amini; Abbasi, Mehdi; Kasmaei, Hosein Delavar; Ashrafi, Farzad; Gharagozli, Kurosh; Assarzadegan, Farhad; Behnam, Behdad; Arabahmadi, Mehran

doi:10.1159/000458521

Cited by 10 publications

(7 citation statements)

References 22 publications

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“…Hence, no direct comparison between our findings and other studies is conceivable. However, compared to previous studies on MLC601 in dementia, 14 , 15 our study findings on VaD are promising.…”

Section: Discussionsupporting

confidence: 52%

MLC601 in vascular dementia: an efficacy and safety pilot study

Pakdaman¹,

Harandi²,

Gharagozli³

et al. 2017

NDT

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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 (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.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.

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Section: Discussionsupporting

confidence: 52%

MLC601 in vascular dementia: an efficacy and safety pilot study

Pakdaman¹,

Harandi²,

Gharagozli³

et al. 2017

NDT

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“…Therapeutic advantages of MLC901 have already been depicted in patients suffering from stroke, Alzheimer's disease, mild cognitive impairment and vascular dementia [4][5][6]. Consistent with findings of clinical reports in efficacy and safety of MLC901, animal studies…”

Section: Introductionsupporting

confidence: 70%

MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo- Controlled Trial

Pakdaman¹,

Harandi

Esfandani

et al. 2020

OAJCAM

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Background: Despite recent developments in intensive care for patients with Traumatic brain injury (TBI), the long-term neurological disabilities still exist. MLC901 is Traditional Chinese Medicine and has shown some neuroprotective and neuro regenerative benefits after brain injury in previous animal and human studies and may provide a new therapeutic approach in the treatment of TBI. Accordingly, we conducted this pilot, randomized, double-masked, placebo-controlled study to investigate the efficacy of MLC901 in patients with moderate to severe TBI. Materials and Methods:Patients with a diagnosis of moderate to severe TBI were enrolled. Subjects were randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months. Evaluation of patients was carried out at baseline, 3 rd month and 6 th month follow-after injury. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) were used to examine patients. Efficacy was evaluated by comparing these two scores between the 2 groups at follow-up visits.Results: Eighty-one patients complete 6 months follow up. There was no significant difference between two study groups regarding the demographic features, interval between injury and start of intervention and length of ICU stay. However, functional outcome scales of GOS, MRS at 3 rd and 6 th month post-injury were significantly better in MLC901 group compared to placebo (p<0.05). Conclusion:MLC901 has shown promising efficacy in patients suffering from moderate to severe TBI.

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“…The present study was carried out to evaluate the long-term efficacy and safety of MLC601 in patients with mild to moderate AD. The rationale behind this study is supported by current evidence on the long-term efficacy of MLC601 in poststroke recovery, by positive results in the treatment of dementia and minimal cognitive impairment [ 11 , 12 , 13 , 14 ], and by the possible role of MLC601 in the modulation of the amyloid precursor protein and in decreasing tau phosphorylation [ 15 , 16 ]. Therefore, we speculate that treatment with MLC601 could be beneficial to patients at early stages of AD.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of MLC601 in Patients with Mild to Moderate Alzheimer Disease: An Extension 4-Year Follow-Up Study

Pakdaman¹,

Gharagozli²,

Abbasi³

et al. 2018

Dement Geriatr Cogn Disord Extra

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Background and Aim: Alzheimer disease (AD) is the most common cause of dementia. Currently, there is no disease-modifying therapy for AD. We aimed to evaluate the long-term efficacy and safety of MLC601 in the treatment of AD. Methods: In this open-label extension study, patients with mild to moderate AD according to DSM-IV criteria were recruited. Patients received MLC601 capsules 3 times a day for 4 years. Cognitive function was assessed every 6 months using Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores. Safety profiles, including adverse events (AEs), and treatment-related abnormality in laboratory tests were also reported. Results: Of a total of 122 patients, 105 completed the study. The mean age was 66.8 ± 6.3 years at the beginning of the study. Sixty-five (61.9%) were female. The mean (±SD) change in MMSE and ADAS-Cog scores at the end of the study was 2.1 (±3.8) and –5.1 (±8.7), respectively. Repeated measure analysis revealed a statistically significant change in both scores (p < 0.001). No patient left the study due to an AE. No abnormality was noted in lab tests. Gastrointestinal symptoms were the most commonly reported AEs. Conclusion: The efficacy of treating AD patients with MLC601 over 4 years has been demonstrated in the present study. Overall, it seems that the safety and efficacy of MLC601 is promising compared to currently prescribed treatments.

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Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

Cited by 10 publications

References 22 publications

MLC601 in vascular dementia: an efficacy and safety pilot study

MLC601 in vascular dementia: an efficacy and safety pilot study

MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo- Controlled Trial

Efficacy and Safety of MLC601 in Patients with Mild to Moderate Alzheimer Disease: An Extension 4-Year Follow-Up Study

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