Clinical trial NCT01847924: NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects
Official title: NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects : a Pilot Double Blind, Placebo-controlled Randomized Trial on Efficacy and Safety (NEURITES) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Impairment
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 103
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who have suffered from stroke may develop problems with thinking. Moreover, such patients have a high risk of becoming demented, more dependent or dying. Therefore, further studies are urgently needed to find effective and safe treatments.

Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain cells and connections in animals. Neuroaid may improve blood flow in the brain and functional recovery after stroke in patients. Neuroaid-II is a simplified formula with only the main 9 herbal ingredients of the original formula and no animal ingredients.

The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after stroke. The study aims to investigate the effectiveness of the study drug in improving cognitive performance. The safety of the study drug will be closely monitored using adverse events, laboratory tests and vital signs.

The trial is important as it aims to set new standards for the scientific evaluation of Asian Traditional Medicine for integration into standard medicine practice. It may potentially establish a novel therapeutic approach for improving cognition after stroke.

Detailed description: A substantial proportion of patients after non-disabling stroke are cognitively impaired compared to aged and education matched community dwelling controls. Moreover, post-stroke patients who have vascular cognitive impairment not 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 absence of evidence based treatment options.

Neuroaid is a Traditional Chinese Medicine which has been shown to induce neurogenesis, promote cell proliferation and stimulate development of axonal and dendritic networks in animal models. Neuroaid may improve functional recovery after stroke in patients. Neuroaid-II is a simplified formulation with only 9 herbal and no animal ingredients.

The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is a 24-week Phase II study. The primary outcome is executive function as measured by the Verbal Fluency test. Secondary outcomes include cognitive measures such as the ADAS-Cog, MoCA, MMSE and a Cognitive Battery; Activities of Daily Living as measured by the ADCS-ADL scale; behaviour as measured by the Neuropsychiatric Inventory and depression as measured by the Geriatric Depression Scale and Beck Depression Scale. Safety and tolerability will be assessed using adverse events, laboratory tests, and vital signs.

The trial is important for translational medicine in Singapore through setting new standards for systematic evaluation of Traditional Medicine for integration into standard medicine practice

Eligibility criteria: Inclusion Criteria:

1. Male and female patients
2. Aged 55 to 85, living with a caregiver,
3. Modified Rankin score \<=3.
4. Diagnosis of CIND due to cerebrovascular disease.
5. Cognitive impairment documented by neuropsychological evaluation within 12 months of index stroke/TIA. Not demented by DSM-IV criteria
6. Written informed consent by subject

Exclusion Criteria:

1. Advanced, severe, and unstable disease of any type that may interfere with the efficacy evaluations or put the subject at special risk.
2. DSM IV current diagnosis of dementia or major depression (patients may be included if currently being treated on an antidepressant and stabilized after 3 months).
3. A disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty).
4. Ingestion of any of the following : an investigational drug in the past four weeks, a drug or treatment known to cause major organ system toxicity during the past four weeks, acetylcholinesterase inhibitors or memantine in the past 3 months

Primary outcomes:
measure: Comparative change on executive function
timeFrame: Baseline to 24th week(24 week)
Secondary outcomes:
measure: Comparative change on cognitive function
timeFrame: Baseline to 24th week(24 week)
measure: Effects on activities of daily living
timeFrame: Baseline to 24th week(24 week)
measure: Effects on behaviour
timeFrame: Baseline to 24th week(24 week)
measure: Effects on depression
timeFrame: 24 week
measure: Adverse events, laboratory tests, and vital signs.
timeFrame: Baseline to 24th week(24 week)
Other outcomes:
Locations:
city: Manila City
country: Philippines
facility: University of Santo Tomas Hospital
state: Metro Manila
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Neuroscience Institute
city: Hanoi
country: Vietnam
facility: National Geriatric Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Christopher LH Chen, FRCP
role: PRINCIPAL_INVESTIGATOR
References: