OBJECTIVE: The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD). METHOD: This was a randomized, double-blind, placebo-controlled clinical trial conducted at 42 U.S. sites. Participants were 403 outpatients with mild to moderate AD and Mini-Mental State Examination scores of 10-22 randomized tomemantine (20 mg/day; N=201) or placebo (N=202) for 24 weeks. Primary outcomes were change from baseline at 24 weeks on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), a measure of cognition, and on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), a global measure. Secondary outcomes included change on the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL(23)), measures of behavior and function, respectively. RESULTS: Most (82.4%) participants completed the trial. Memantine resulted in significantly better outcomes than placebo on measures of cognition, global status, and behavior when based on the protocol-specified primary last observation carried forward imputation as well as a mixed-models repeated-measures approach applied to the continuous outcomes. Treatment discontinuations because of adverse events for memantine versus placebo were 19 (9.5%) and 10 (5.0%), respectively. CONCLUSIONS: These results support the safety and efficacy of memantine for the treatment of mild to moderate AD.
RCT Entities:
OBJECTIVE: The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD). METHOD: This was a randomized, double-blind, placebo-controlled clinical trial conducted at 42 U.S. sites. Participants were 403 outpatients with mild to moderate AD and Mini-Mental State Examination scores of 10-22 randomized to memantine (20 mg/day; N=201) or placebo (N=202) for 24 weeks. Primary outcomes were change from baseline at 24 weeks on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), a measure of cognition, and on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), a global measure. Secondary outcomes included change on the Neuropsychiatric Inventory (NPI) and the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL(23)), measures of behavior and function, respectively. RESULTS: Most (82.4%) participants completed the trial. Memantine resulted in significantly better outcomes than placebo on measures of cognition, global status, and behavior when based on the protocol-specified primary last observation carried forward imputation as well as a mixed-models repeated-measures approach applied to the continuous outcomes. Treatment discontinuations because of adverse events for memantine versus placebo were 19 (9.5%) and 10 (5.0%), respectively. CONCLUSIONS: These results support the safety and efficacy of memantine for the treatment of mild to moderate AD.
Authors: Maurice W Dysken; Mary Sano; Sanjay Asthana; Julia E Vertrees; Muralidhar Pallaki; Maria Llorente; Susan Love; Gerard D Schellenberg; J Riley McCarten; Julie Malphurs; Susana Prieto; Peijun Chen; David J Loreck; George Trapp; Rajbir S Bakshi; Jacobo E Mintzer; Judith L Heidebrink; Ana Vidal-Cardona; Lillian M Arroyo; Angel R Cruz; Sally Zachariah; Neil W Kowall; Mohit P Chopra; Suzanne Craft; Stephen Thielke; Carolyn L Turvey; Catherine Woodman; Kimberly A Monnell; Kimberly Gordon; Julie Tomaska; Yoav Segal; Peter N Peduzzi; Peter D Guarino Journal: JAMA Date: 2014-01-01 Impact factor: 56.272
Authors: Maurice W Dysken; Peter D Guarino; Julia E Vertrees; Sanjay Asthana; Mary Sano; Maria Llorente; Muralidhar Pallaki; Susan Love; Gerard D Schellenberg; J Riley McCarten; Julie Malphurs; Susana Prieto; Peijun Chen; David J Loreck; Sara Carney; George Trapp; Rajbir S Bakshi; Jacobo E Mintzer; Judith L Heidebrink; Ana Vidal-Cardona; Lillian M Arroyo; Angel R Cruz; Neil W Kowall; Mohit P Chopra; Suzanne Craft; Stephen Thielke; Carolyn L Turvey; Catherine Woodman; Kimberly A Monnell; Kimberly Gordon; Julie Tomaska; Govind Vatassery Journal: Alzheimers Dement Date: 2013-04-11 Impact factor: 21.566
Authors: David B Hogan; Peter Bailey; Sandra Black; Anne Carswell; Howard Chertkow; Barry Clarke; Carole Cohen; John D Fisk; Dorothy Forbes; Malcolm Man-Son-Hing; Krista Lanctôt; Debra Morgan; Lilian Thorpe Journal: CMAJ Date: 2008-11-04 Impact factor: 8.262