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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

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ClinicalTrials.gov Identifier: NCT01696123
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: MLC601 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Primary Completion Date : January 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MLC601
MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.
Drug: MLC601
It was described
Other Name: NeuroAid


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. to measure included adverse events (AEs) [ Time Frame: every 4 weeks ]
    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.

  2. measuring withdrawal rate [ Time Frame: every 4 weeks ]
    measuring any withdrawal rate among intervention group


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • uncontrolled diabetes mellitus
  • hypertension
  • unstable cardiac disease
  • severe obstructive pulmonary disease
  • renal or hepatic failure
  • and/or other life threatening conditions
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696123


Locations
Iran, Islamic Republic of
Loghman Hospital
Tehran, Iran, Islamic Republic of, 1315693446
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Ali Amini, M.D Shahid Beheshti University of Medical Sciences, Tehran, Iran
More Information

Responsible Party: Ali Amini Harandi, Dr, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01696123     History of Changes
Other Study ID Numbers: SBMU-1391
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by Ali Amini Harandi, Shaheed Beheshti Medical University:
Alzheimer disease
Cholinesterase inhibitors
MLC601
NeuroAiD
neuroprotection
neuroregeneration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders