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 Identifier: NCT01696123|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : September 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: MLC601||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||August 2012|
MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.
It was described
Other Name: NeuroAid
- 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.
- 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.
- measuring withdrawal rate [ Time Frame: every 4 weeks ]measuring any withdrawal rate among intervention group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696123
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 1315693446|
|Principal Investigator:||Ali Amini, M.D||Shahid Beheshti University of Medical Sciences, Tehran, Iran|