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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore

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