Cognitive ImpairmentPhase 2NEURITESNCT01847924
NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects
A Phase 2 study testing MLC901 in people with Cognitive Impairment, run by National University Hospital, Singapore at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- MLC901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2013to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Singapore3 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
National Neuroscience Institute
Singapore, 308433
Philippines1 site
University of Santo Tomas Hospital
Manila, National Capital Region, 1015
About this study
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
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.
Read more
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.
Read the 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
- Conditions
- Cognitive Impairment
- Being tested
- MLC901, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC901Drug
Also called NeuroaidII (MLC901)
24 weeks intervention with orally MLC901. 2 capsules 3 times a day
PlaceboDrug
Also called MLC901 matched Placebo
24 weeks intervention with orally placebo. 2 capsules 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| MLC901 | Active comparator | Brand: Neuroaid II. Dosage: 2 capsules 3 times a a day Receives: Drug: MLC901 |
| placebo | Placebo comparator | MLC901 matching placebo made by the same manufacturer for this study dosage: 2 capsules 3 times a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 24th week(24 week)
Secondary outcomes (5)
Comparative change on cognitive function
To evaluate the comparative change from baseline with Neuroaid and placebo on cognitive function, as measured by:
ADAS-Cog MoCA Cognitive Battery (Symbol Digits Modalities Test, Maze, Digit Cancellation Test, Clock Drawing Test, Visual Memory Test and Frontal Assessment Battery)
Measured: Baseline to 24th week(24 week)
Effects on activities of daily living
To evaluate the effects of Neuroaid on activities of daily living by :
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment (MCI)
Measured: Baseline to 24th week(24 week)
Effects on behaviour
To evaluate the effects of Neuroaid on behaviour by : Neuropsychiatric Inventory (NPI)
Measured: Baseline to 24th week(24 week)
Effects on depression
To evaluate the effects of Neuroaid on depression by : Geriatric Depression Scale (GDS)
Measured: 24 week
Adverse events, laboratory tests, and vital signs.
To evaluate the safety and tolerability of ML901 for 24 weeks of treatment, in comparison with placebo. Safety will be assessed using adverse events, laboratory tests, and vital signs.
Measured: Baseline to 24th week(24 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher LH Chen, FRCP, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847924
- Sponsor's protocol ID
- MLC901-1
- Acronym
- NEURITES
- Status last verified
- Jun 2018
- First submitted
- 3 May 2013
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01847924
- Acronym / sponsor ID
- NEURITES / MLC901-1
- Conditions
- Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLC901 | Active comparator | Drug: MLC901Brand: Neuroaid II. Dosage: 2 capsules 3 times a a day |
| placebo | Placebo comparator | Drug: PlaceboMLC901 matching placebo made by the same manufacturer for this study dosage: 2 capsules 3 times a day. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLC901Also: NeuroaidII (MLC901)24 weeks intervention with orally MLC901. 2 capsules 3 times a day | Drug | MLC901 |
| PlaceboAlso: MLC901 matched Placebo24 weeks intervention with orally placebo. 2 capsules 3 times a day | Drug | placebo |
Primary outcome
Comparative change on executive function
Time frame: Baseline to 24th week(24 week)
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
5 secondary outcomes
Comparative change on cognitive function
Time frame: Baseline to 24th week(24 week)
Effects on activities of daily living
Time frame: Baseline to 24th week(24 week)
Effects on behaviour
Time frame: Baseline to 24th week(24 week)
Effects on depression
Time frame: 24 week
Adverse events, laboratory tests, and vital signs.
Time frame: Baseline to 24th week(24 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher LH Chen, FRCP principal investigator
National University Hospital, Singapore
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLC901 in people with Cognitive Impairment, run by National University Hospital, Singapore at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore, Philippines, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative change on executive function (time frame: Baseline to 24th week(24 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.