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

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.

Neurocognitive profile of patients with X-linked dystonia-parkinsonism.

X-linked dystonia-parkinsonism (XDP) is a debilitating movement disorder endemic to the Panay Island, Philippines. Most studies focus on motor symptoms, hence we reviewed the neurocognitive profile of XDP patients. Neurocognitive testing of XDP patients focused on five domains: general intellectual functioning, episodic memory, language, attention and executive function, and affect. Twenty-nine genetically confirmed patients were included. Twenty-six (89.6%) had impairments in one or more domains, while only three had no impairment in any domain. Attention and executive function was the most commonly affected domain (n = 23, 79.3%). Deficits in general intellect, episodic memory, attention and executive function and affect were seen in our subset of XDP patients. The striatal pathology affecting the frontostriatal circuitry mandating these cognitive processes is mainly implicated in these impairments. The results of our study provided further evidence on the extent of cognitive impairment in XDP using a select battery of neurocognitive tests.

Nonmotor features in sex-linked dystonia parkinsonism.

The natural history of sex-linked dystonia parkinsonism (XDP) has been well documented. However, its nonmotor features have not yet been fully described. We reviewed the available literature on the nonmotor features in XDP. We found five articles involving 79 XDP patients, three of which were on cognition and two on mood (anxiety and depression). There were two case reports showing executive dysfunction. The other paper showed impairments in abstract thinking and motor programming. Two articles were on mood (anxiety and depression). The prevalence of anxiety symptoms was 16.7% and 54.8-92.9% had depressive symptoms. The identification of these nonmotor features should lead to early and appropriate management.

Montreal cognitive assessment (MoCA) and mini-mental state examination (MMSE) as screening tools for cognitive impairment among patients with idiopathic Parkinson's disease: A descriptive study

OBJECTIVE: To compare the scores of patients with idiopathic Parkinson's Disease using the Montreal Cognitive Assessment and Mini-Mental State Examination in a tertiary hospital BACKGROUND: Parkinson's Disease (PD) is a neurodegenerative disorder diagnosed clinically based on the signs of resting tremor bradykinesia, rigidity and loss of postural reflexes. According to Bassett et al, 20% to 40% of PD patients ultimately become demented with an incidence of 10% per year. Cognitive decline is an impotant predictor of dementia in PD. Almost all patients with PD suffer from selective cognitive impairments including difficulties with attention, concentration, planning, sequencing, concept formation, problem solving, set-shifting and memory which are thought ro reflect dysfunction of cortical circuits subserving frontal brain regions. Identification of cognitive impairment in PD is crucial. It predicts future cognitive decline and may eventually be a target for pharmacologic intervention to prevent or delay the development of dementia. METHODS: A descriptive study. A convenience sampling of 95 patients with idiopathic Patkinson's disease were screened for cognitive impairment. RESULTS: Mean MMSE and MoCA scores were 26.1 (SD 2.9) and 19.8 (SD 4.28). Based on the published cutoff scores for cognitive impairment for Parkinson's Disease, 72% of the participants scored 26/30 and below on MoCA whereas only 42% scored 26/30 and below on the MMSE. Impairments were seen in numerous cognitive domains including executive function, language, recent semantic memory, visuo-spatial processing and constructional praxis. Predictors of cognitive impairment on the MoCA include low level of education and older age. CONCLUSIONS: MoCA was able to detect more cognitive impairments in patients with Parkinson's disease than MMSE. Therefore, MoCA is a better screening tool to detect cognitive impairments in PD patients.

The effects of anesthesia on the memory of surgical patients

The aim of this study was to determine if anesthesia has any influence on human memory.