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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

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

September 21, 2012
September 27, 2012
January 2011
January 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01696123 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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
Not Provided

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer Disease
Drug: MLC601
It was described
Other Name: NeuroAid
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.
Intervention: Drug: MLC601
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
August 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01696123
SBMU-1391
Not Provided
Ali Amini Harandi, Shaheed Beheshti Medical University
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Ali Amini, M.D Shahid Beheshti University of Medical Sciences, Tehran, Iran
Shahid Beheshti Medical University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP