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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Amini Harandi, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01696123
First received: September 21, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: MLC601
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements [ Time Frame: every 4 weeks up to 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • to measure included adverse events (AEs) [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    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.

  • measuring withdrawal rate [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    measuring any withdrawal rate among intervention group


Enrollment: 125
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696123

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

No publications provided

Responsible Party: Ali Amini Harandi, Dr, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01696123     History of Changes
Other Study ID Numbers: SBMU-1391
Study First Received: September 21, 2012
Last Updated: September 27, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014