MLC601 in vascular dementia: an efficacy and safety pilot study

Hossein Pakdaman,1 Ali Amini Harandi,1 Koroush Gharagozli,1 Mehdi Abbasi,1 Majid Ghaffarpour,2 Farzad Ashrafi,1 Hosein Delavar Kasmaei,1 Asghar Amini Harandi3 1Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; 2Iranian Center of Neurological Research, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran; 3Department of Biochemistry, School of Medicine, Jiroft University of Medical Sciences, Jiroft, Iran Background and aim: Vascular 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. Methods: In 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. Results: Eighty-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. Conclusion: Patients 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. Keywords: vascular dementia, MLC601, safety, randomized placebo-controlled tria

Burden of tension-type headache in the Middle East and North Africa region, 1990-2019

Introduction Tension-type headache (TTH) is the most prevalent neurological disorder. As there is a gap in the literature regarding the disease burden attributable to TTH in the Middle East and North Africa (MENA) region, the aim of the present study was to report the epidemiological indicators of TTH in MENA, from 1990 to 2019, by sex, age and socio-demographic index (SDI). Methods Publicly available data on the point prevalence, annual incidence and years lived with disability (YLDs) were retrieved from the global burden of disease (GBD) 2019 study for the 21 countries and territories in MENA, between 1990 and 2019. The results were presented with numbers and age-standardised rates per 100000 population, along with their corresponding 95% uncertainty intervals (UIs). Results In 2019, the age-standardised point prevalence and annual incidence rates for TTH in the MENA region were 24504.5 and 8680.1 per 100000, respectively, which represents a 2.0% and a 0.9% increase over 1990-2019, respectively. The age-standardised YLD rate of TTH in this region in 2019 was estimated to be 68.1 per 100000 population, which has increased 1.0% since 1990. Iran [29640.4] had the highest age-standardised point prevalence rate for TTH, while Turkey [21726.3] had the lowest. In 2019, the regional point prevalence of TTH was highest in the 35-39 and 70-74 age groups, for males and females, respectively. Furthermore, the number of prevalent cases was estimated to be highest in those aged 35-39 and 25-29 years, in both males and females, respectively. Moreover, the burden of TTH was not observed to have a clear association with SDI. Conclusions While the prevalence of TTH in the MENA region increased from 1990 to 2019, the incidence rate did not change. In addition, the burden of TTH in MENA was higher than at the global level for both sexes and all age groups. Therefore, prevention of TTH would help alleviate the attributable burden imposed on the hundreds of millions of people suffering from TTH around the region

Measurement and associative factors of adherence to epilepsy drug treatment among the elderly population in Tehran (Iran)

Purpose The objective of this survey was to measure adherence and to identify correlation and prediction factors related to noncompliance among the elderly in Tehran, Iran. Methods A population-based survey was carried out among the elderly (≥60 years of age) by using Tehran Epilepsy registry. All subjects were contacted by telephone and invited for face-to-face consultation. Questionnaires used were the following: Medication Adherence Rating Scale (MARS); Medical Prescription Knowledge (MPK); Abbreviated Mental Test (AMT). Along with customary descriptive statistics, a simple chi-square test (or Fischer exact test if value of cells was ≤5) was used for correlating; Cramer's V was used for strength of association, and prediction was by logistic regression. Results Out of 104 subjects’ approached, 23 subjects (median age 62.0, 95% CI 61.0–64.7, range 60–71; 73.9% males; 78.3% married and having a living partner; 54.5% epilepsy as supernatural; 21.7% with comorbid condition) participated. Most did not have a recent epilepsy onset (n = 20, 86.8%), or had active epilepsy (n = 22, 95.7%), convulsive seizures (n = 21, 91.3%), with no (n = 13, 56.5%) to low seizure number, and polytherapy (n = 12, 52.2%). Median MARS score was 8.0 (95% CI 6.0–8.0, range 3–10). Nonadherence was correlated to comorbidity (p = 0.003) and widowhood or divorcehood (p = 0.04) and predicted by the same factors. Treatment side effects altered behavior (p = 0.03), and unsteadiness (p = 0.01) was also associated with nonadherence. MPK was positive for all participants. Median AMT score was 9.0 (95% CI 9.0–10.0, range 6–10). Conclusion Elderly patients had a high treatment adherence and, as logically expected, were associated with comorbid state, divorce-widowhood, and drug-related behavioral side effects particularly behavioral and unsteadiness. © 201

Amyotrophic lateral sclerosis progression: Iran-ALS clinical registry, a multicentre study

This study was designed to evaluate ALS progression among different subgroups of Iranian patients. Three hundred and fifty-eight patients from centres around the country were registered and their progression rate was evaluated using several scores including Manual Muscle Test scoring (MMT) and the revised ALS Functional Rating Scale (ALSFRS-R). Progression rate was analysed separately in subgroups regarding gender, onset site, stage of disease and riluzole consumption. A significant difference in MMT deterioration rate (p = 0.01) was noted between those who used riluzole and those who did not. No significant difference was observed in progression rates between male/female and bulbar-onset/limb-onset groups using riluzole. In conclusion, riluzole has a significant effect on muscle force deterioration rate but not functional scale. Progression rate was not influenced by site of onset or gender