Clinical trial NCT01696123: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer disease
Cholinesterase inhibitors
MLC601
NeuroAiD
neuroprotection
neuroregeneration
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
timeFrame: every 4 weeks up to 18 months
measure: changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements
timeFrame: every 4 weeks up to 18 months
Secondary outcomes:
measure: to measure included adverse events (AEs)
timeFrame: every 4 weeks
measure: measuring withdrawal rate
timeFrame: every 4 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Loghman Hospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Ali Amini, M.D
role: PRINCIPAL_INVESTIGATOR
References: