PMID- 18288936 OWN - NLM STAT- MEDLINE DCOM- 20080506 LR - 20220331 IS - 1567-2050 (Print) IS - 1567-2050 (Linking) VI - 5 IP - 1 DP - 2008 Feb TI - Memantine treatment in patients with mild to moderate Alzheimer's disease already receiving a cholinesterase inhibitor: a randomized, double-blind, placebo-controlled trial. PG - 83-9 AB - OBJECTIVE: To evaluate the efficacy and safety of memantine in patients with mild to moderate Alzheimer's disease (AD) receiving cholinesterase inhibitor (ChEI) treatment. METHODS: Participants (N= 433) with probable AD, Mini-Mental State Exam (MMSE) scores between 10-22 (inclusive), and concurrent stable use of ChEIs (donepezil, rivastigmine, galantamine) were randomized to placebo or memantine (20 mg once daily) for 24 weeks. Primary outcomes were changes from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) score. Secondary measures comprised the 23-item Alzheimer Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL(23)), Neuropsychiatric Inventory (NPI), and MMSE. RESULTS: At the end of the trial, there were no statistically significant differences between the memantine- and placebo group on primary and secondary outcome measures. The incidence of adverse events (AEs) was similar between the two groups, with no AE occurring in more than 5% of memantine-treated patients and at a rate twice that of the placebo group. CONCLUSIONS: In this trial, memantine did not show an advantage over placebo based on protocol-specified primary or secondary analyses in patients with mild to moderate AD on stable ChEI regimens. There were no significant differences in tolerability and safety between the memantine- and placebo groups. FAU - Porsteinsson, Anton P AU - Porsteinsson AP AD - Alzheimer's Disease Care, Research and Education Program, University of Rochester, School of Medicine and Dentistry, Rochester, NY 14620, USA. Anton_Porsteinsson@urmc.rochester.edu FAU - Grossberg, George T AU - Grossberg GT FAU - Mintzer, Jacobo AU - Mintzer J FAU - Olin, Jason T AU - Olin JT CN - Memantine MEM-MD-12 Study Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United Arab Emirates TA - Curr Alzheimer Res JT - Current Alzheimer research JID - 101208441 RN - 0 (Cholinesterase Inhibitors) RN - 0 (Excitatory Amino Acid Antagonists) RN - 0 (Receptors, N-Methyl-D-Aspartate) RN - W8O17SJF3T (Memantine) SB - IM MH - Activities of Daily Living MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy/psychology MH - Cholinesterase Inhibitors/*therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Excitatory Amino Acid Antagonists/*therapeutic use MH - Humans MH - Memantine/*therapeutic use MH - Mental Status Schedule MH - Middle Aged MH - Neuropsychological Tests MH - Prospective Studies MH - Receptors, N-Methyl-D-Aspartate/*antagonists & inhibitors MH - Severity of Illness Index MH - Treatment Outcome FIR - Au, W IR - Au W FIR - Baumel, B IR - Baumel B FIR - Wilks, K IR - Wilks K FIR - Blass, J IR - Blass J FIR - Cooper, G IR - Cooper G FIR - Eisner, L IR - Eisner L FIR - Lossada, M IR - Lossada M FIR - Forchetti, C IR - Forchetti C FIR - Grossberg, G IR - Grossberg G FIR - Grosz, D IR - Grosz D FIR - Kirby, L IR - Kirby L FIR - Lipton, A IR - Lipton A FIR - Littlejohn, T 3rd IR - Littlejohn T 3rd FIR - Losk, S IR - Losk S FIR - Ott, B IR - Ott B FIR - Pfeiffer, E IR - Pfeiffer E FIR - Potkin, S IR - Potkin S FIR - Sadowsky, C IR - Sadowsky C FIR - Safirstein, B IR - Safirstein B FIR - Seiden, D IR - Seiden D FIR - Shua-Haim, J IR - Shua-Haim J FIR - Stark, S IR - Stark S FIR - Thein, S IR - Thein S FIR - Tuchman, M IR - Tuchman M FIR - van Dyck, C IR - van Dyck C FIR - Booker, G IR - Booker G FIR - Harris, B IR - Harris B FIR - Margolin, D IR - Margolin D FIR - Ferguson, J IR - Ferguson J FIR - Moldauer, L IR - Moldauer L FIR - Pomara, N IR - Pomara N FIR - Dubovsky, S IR - Dubovsky S FIR - Mintzer, J IR - Mintzer J FIR - Wilks, K IR - Wilks K FIR - Porsteinsson, A IR - Porsteinsson A FIR - Tilker, H IR - Tilker H FIR - Wallace, J IR - Wallace J FIR - Heiser, J IR - Heiser J FIR - Ferris, S IR - Ferris S FIR - Bartel, D IR - Bartel D FIR - Kobetz, S IR - Kobetz S FIR - Doody, R IR - Doody R EDAT- 2008/02/22 09:00 MHDA- 2008/05/07 09:00 CRDT- 2008/02/22 09:00 PHST- 2008/02/22 09:00 [pubmed] PHST- 2008/05/07 09:00 [medline] PHST- 2008/02/22 09:00 [entrez] AID - 10.2174/156720508783884576 [doi] PST - ppublish SO - Curr Alzheimer Res. 2008 Feb;5(1):83-9. doi: 10.2174/156720508783884576.