Alzheimer DiseasePhase 2NCT01696123
Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine
A Phase 2 study testing MLC601 in people with Alzheimer Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MLC601
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Aug 2012
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 50 years old
- met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- failed treatment with the cholinesterase inhibitor Rivastigmine for any reason
Who cannot join
- uncontrolled diabetes mellitus
- hypertension
- unstable cardiac disease
- severe obstructive pulmonary disease
- renal or hepatic failure
- and/or other life threatening conditions
Trial locations and contacts
1 site in 1 country.
About this study
Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastigmine.
Read the detailed description
An 18-month open-label pilot study would be conducted at three university referral centres in Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline medical history will be taken and physical examination will be performed for all participants, and any comorbidities and concomitant therapies would be noted. Patients with controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601 will be prescribed as one capsule three times daily without an escalation dose. Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.
- Conditions
- Alzheimer Disease
- Being tested
- MLC601
- Keywords
- Alzheimer disease, Cholinesterase inhibitors, MLC601, NeuroAiD, neuroprotection, neuroregeneration
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC601Drug
Also called NeuroAid
It was described
| Study group | Role | What they receive |
|---|---|---|
| MLC601 | Experimental | MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose. Receives: Drug: MLC601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
Measured: every 4 weeks up to 18 months
changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements
change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
Measured: every 4 weeks up to 18 months
Secondary outcomes (2)
to measure included adverse events (AEs)
Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. AEs were defined as any sign, symptom, syndrome or disease that occurred for the first time or worsened after baseline, whether they were considered treatment related.
Measured: every 4 weeks
measuring withdrawal rate
measuring any withdrawal rate among intervention group
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Amini Harandi, Shahid Beheshti University of Medical Sciences
- Investigators
- Ali Amini, M.D, Principal investigator, Shahid Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696123
- Sponsor's protocol ID
- SBMU-1391
- Status last verified
- Sep 2012
- First submitted
- 21 Sep 2012
- Last updated
- 28 Sep 2012
- Results posted
- No
Publications
Pakdaman H, Amini Harandi A, Gharagozli K, Siavoshi F, Shirzadeh Barough S, Sharifipour E, Esfandani A, Ilkhani S, Tabatabaei FS, Sobhanian SA. A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study. Curr Aging Sci. 2023;16(3):234-239. doi: 10.2174/1874609816666230224111759.
PubMed 36843256
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine
- ClinicalTrials.gov ID
- NCT01696123
- Acronym / sponsor ID
- SBMU-1391
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Cholinesterase inhibitors, MLC601, NeuroAiD, neuroprotection, neuroregeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Sep 2012 (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.
Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastigmine.
Detailed description
An 18-month open-label pilot study would be conducted at three university referral centres in Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline medical history will be taken and physical examination will be performed for all participants, and any comorbidities and concomitant therapies would be noted. Patients with controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601 will be prescribed as one capsule three times daily without an escalation dose. Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MLC601 | Experimental | Drug: MLC601MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 50 years old
- met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- failed treatment with the cholinesterase inhibitor Rivastigmine for any reason
Key exclusion criteria (6 listed)
- uncontrolled diabetes mellitus
- hypertension
- unstable cardiac disease
- severe obstructive pulmonary disease
- renal or hepatic failure
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 |
|---|---|---|
| MLC601Also: NeuroAidIt was described | Drug | MLC601 |
Primary outcome
changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
Time frame: every 4 weeks up to 18 months
change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements
Time frame: every 4 weeks up to 18 months
change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
2 secondary outcomes
to measure included adverse events (AEs)
Time frame: every 4 weeks
measuring withdrawal rate
Time frame: every 4 weeks
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 28 Sep 2012.
- Derived from this study: PubMed 36843256Pakdaman H, Amini Harandi A, Gharagozli K, Siavoshi F, Shirzadeh Barough S, Sharifipour E, Esfandani A, Ilkhani S, Tabatabaei FS, Sobhanian SA. A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study. Curr Aging Sci. 2023;16(3):234-239. doi: 10.2174/1874609816666230224111759.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Ali Amini, M.D principal investigator
Shahid Beheshti University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLC601 in people with Alzheimer Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 6 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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. 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?
changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements (time frame: every 4 weeks up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696123, which also lists 1 linked publication.
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 28 Sep 2012.