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
|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
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
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 1315693446|
|Principal Investigator:||Ali Amini, M.D||Shahid Beheshti University of Medical Sciences, Tehran, Iran|