title: The NeuroAiD II (MLC901) in vascular cognitive impairment study (NEURITES).
abstract: BACKGROUND
  A substantial proportion of patients after nondisabling stroke are cognitively impaired compared to age- and education-matched community-dwelling controls. Moreover, poststroke patients who have 'vascular cognitive impairment no dementia' (VCIND) of moderate severity have a high risk of incident dementia, dependency and death. Further studies are urgently needed to demonstrate effective cognition-enhancing therapies in VCIND given the scarcity of evidence-based treatment options. NeuroAiD is a traditional Chinese medicine that has been shown to induce neuroplasticity, promote cell proliferation and stimulate the development of dense axonal and dendritic networks in animal stroke models. NeuroAiD may improve cerebral blood flow and functional recovery after stroke in patients.
  
  
  OBJECTIVE
  To investigate the effects and tolerability of NeuroAiD II in patients with VCIND.
  
  
  METHODS
  The NeuroAiD II (MLC901) in Vascular Cognitive Impairment Study (NEURITES) is a 24-week, double-blind, randomized, placebo-controlled phase II study of NeuroAiD II in patients with VCIND. The primary outcome is executive function as measured by the Verbal Fluency test. Secondary outcomes include cognitive assessments such as the ADAS-Cog, MoCA, MMSE and Cognitive Battery: activities of daily living as measured by the Alzhei-mer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment, behavior as measured by the Neuropsychiatric Inventory, and depression as measured by the Geriatric Depression Scale and the Beck Depression Scale. In addition, there will be novel exploratory outcomes: (a) magnetic resonance imaging of lesion location (structural imaging), structural integrity of white matter pathways (diffusion tensor imaging), neuronal function (resting studies) and perfusion (arterial spin labeling and MR angiography), and (b) retinal and optic nerve imaging. Safety and tolerability will be assessed using adverse events, laboratory tests and vital signs.
  
  
  CONCLUSIONS
  NEURITES has the potential to set new standards for the systematic evaluation of Asian traditional medicine for integration into standard medicine practice and establishing a novel therapeutic approach for improving cognition after stroke.
authors.affiliation: Department of Pharmacology, National University Health System, Singapore, Singapore. cplhchen @ yahoo.com.sg
authors.forename: Christopher L H
authors.initials: CL
authors.lastname: Chen
authors.forename: Kamran
authors.initials: K
authors.lastname: Ikram
authors.forename: Qiu
authors.initials: Q
authors.lastname: Anqi
authors.forename: Wong Tien
authors.initials: WT
authors.lastname: Yin
authors.forename: Annabel
authors.initials: A
authors.lastname: Chen
authors.forename: Narayanaswamy
authors.initials: N
authors.lastname: Venketasubramanian
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers; D002533:Cerebral Angiography; D002561:Cerebrovascular Disorders / Q000150:complications* / Q000188:drug therapy* / Q000523:psychology; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology* / Q000523:psychology; D003863:Depression / Q000209:etiology / Q000523:psychology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D016032:Randomized Controlled Trials as Topic; D012160:Retina / Q000473:pathology; D018401:Sample Size; D020521:Stroke / Q000150:complications* / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018696:Neuroprotective Agents