Status:
COMPLETED
NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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 urgent...
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 vas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01847924
Start Date
March 1 2013
End Date
April 1 2018
Last Update
July 27 2018
Active Locations (5)
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1
University of Santo Tomas Hospital
Manila, National Capital Region, Philippines, 1015
2
National University Hospital
Singapore, Singapore, 119074
3
Singapore General Hospital
Singapore, Singapore, 169608
4
National Neuroscience Institute
Singapore, Singapore, 308433