NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects

NCT01847924 | Completed Phase 2

• 1 other identifier: MLC901-1
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 5

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Comparative change on executive function

  To evaluate the comparative change from baseline with MLC901 and placebo on executive function in patients with cognitive impairment not dementia due to cerebrovascular disease, as measured by: Verbal Fluency and Colour Trails Test 1 \& 2

  Baseline to 24th week(24 week)

Secondary Outcomes (5)

• Comparative change on cognitive function

  Baseline to 24th week(24 week)

• Effects on activities of daily living

  Baseline to 24th week(24 week)

• Effects on behaviour

  Baseline to 24th week(24 week)

• Effects on depression

  24 week

• Adverse events, laboratory tests, and vital signs.

  Baseline to 24th week(24 week)

Study Arms (2)

MLC901

ACTIVE COMPARATOR

Brand: Neuroaid II. Dosage: 2 capsules 3 times a a day

Drug: MLC901

placebo

PLACEBO COMPARATOR

MLC901 matching placebo made by the same manufacturer for this study dosage: 2 capsules 3 times a day.

Drug: Placebo

Interventions

MLC901 DRUG

24 weeks intervention with orally MLC901. 2 capsules 3 times a day

Also known as: NeuroaidII (MLC901)

MLC901

Placebo DRUG

24 weeks intervention with orally placebo. 2 capsules 3 times a day

Also known as: MLC901 matched Placebo

placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Advanced, severe, and unstable disease of any type that may interfere with the efficacy evaluations or put the subject at special risk.
• 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).
• A disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty).
• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (5)

University of Santo Tomas Hospital

Manila, National Capital Region, 1015, Philippines

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Neuroscience Institute

Singapore, 308433, Singapore

Location

National Geriatric Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christopher LH Chen, FRCP

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-06

Locations

SG (3); VN (1); PH (1)