PMID- 17345042
OWN - NLM
STAT- MEDLINE
DCOM- 20070706
LR  - 20191210
IS  - 0340-5354 (Print)
IS  - 0340-5354 (Linking)
VI  - 254
IP  - 3
DP  - 2007 Mar
TI  - Open label, multicenter, 28-week extension study of the safety and tolerability 
      of memantine in patients with mild to moderate Alzheimer's disease.
PG  - 351-8
AB  - BACKGROUND: Memantine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has 
      been shown to be safe and to have beneficial effects on cognition, function, 
      behavior, and global patient status in patients with Alzheimer's disease (AD) in 
      studies lasting 3-6 months. It is approved in the U.S. and Europe for the 
      treatment of moderate to severe AD and is currently under investigation for mild 
      to moderate AD. OBJECTIVE: To evaluate the long-term safety of memantine in 
      patients with mild to moderate AD and to investigate the tolerability of 
      once-daily dose administration. METHODS: This 28-week study enrolled 314 patients 
      with mild to moderate AD who had completed a 24-week, double-blind, 
      placebo-controlled lead-in clinical trial of memantine in AD. Following an 8-week 
      double-blind dose titration phase (used to assess the tolerability of different 
      dosing regimens), subjects were assigned to continuous open label memantine (10 
      mg, bi.d.) treatment for 20 weeks. Safety outcome measures included 
      treatment-emergent adverse events (AEs), deaths, vital signs, electrocardiograms, 
      and laboratory parameters. RESULTS: During the 28-week study (Phase A+Phase B), 
      the most common AEs were falls and other injuries (both 10.8%). AEs resulted in 
      treatment discontinuation in 6.7% of patients. Discontinuations due to AEs were 
      similar in the once-daily dosing groups compared to the twice-daily dosing 
      groups. During dose titration, completion rates were greater than 90% for both 
      groups. Conversion to once-daily dosing in patients already receiving twice-daily 
      doses of memantine was also well tolerated. CONCLUSIONS: Memantine monotherapy in 
      patients with mild to moderate AD is safe and well tolerated for at least one 
      year. Once-daily dosing during titration and short-term maintenance therapy is 
      safe and well tolerated.
FAU - Ott, Brian R
AU  - Ott BR
AD  - The Alzheimer's Disease & Memory Disorders Center, Rhode Island Hospital-APC 6, 
      593 Eddy Street, Providence, Rhode Island 02903, and Department of Psychiatry, 
      Northwestern University, Chicago, IL 60611, USA. BOtt@lifespan.org
FAU - Blake, Lesley M
AU  - Blake LM
FAU - Kagan, Ethel
AU  - Kagan E
FAU - Resnick, Malca
AU  - Resnick M
CN  - Memantine MEM-MD-11AB Study Group
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070307
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Antiparkinson Agents)
RN  - W8O17SJF3T (Memantine)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy/physiopathology
MH  - Antiparkinson Agents/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Memantine/adverse effects/*therapeutic use
MH  - Neuropsychological Tests
MH  - Outcome Assessment, Health Care
EDAT- 2007/03/09 09:00
MHDA- 2007/07/07 09:00
CRDT- 2007/03/09 09:00
PHST- 2006/02/02 00:00 [received]
PHST- 2006/05/08 00:00 [accepted]
PHST- 2007/03/09 09:00 [pubmed]
PHST- 2007/07/07 09:00 [medline]
PHST- 2007/03/09 09:00 [entrez]
AID - 10.1007/s00415-006-0374-x [doi]
PST - ppublish
SO  - J Neurol. 2007 Mar;254(3):351-8. doi: 10.1007/s00415-006-0374-x. Epub 2007 Mar 7.