PMID- 17243195
OWN - NLM
STAT- MEDLINE
DCOM- 20080110
LR  - 20131121
IS  - 0885-6230 (Print)
IS  - 0885-6230 (Linking)
VI  - 22
IP  - 3
DP  - 2007 Mar
TI  - Safety and tolerability of once-daily versus twice-daily memantine: a randomised, 
      double-blind study in moderate to severe Alzheimer's disease.
PG  - 258-62
AB  - OBJECTIVE: To assess the safety and tolerability of three different dosing 
      schedules of memantine in patients with moderate to severe Alzheimer's disease 
      (AD). METHOD: This 12-week, randomised, double-blind study, investigated three 
      dosing schedules of memantine: OD1 (20 mg once daily with a 1-step up-titration); 
      OD3 (20 mg once daily with a 3-step up-titration); and BID3 (10 mg twice daily 
      with a 3-step up-titration as currently recommended in the memantine labelling). 
      The study comprised 78 patients with moderate to severe AD (DSM-IV-TR criteria; 
      MMSE score < or = 18), 70% of whom were on stable dosing of acetylcholinesterase 
      inhibitor (AChEI) initiated > or = 3 months prior to study start. Safety and 
      tolerability were assessed by the number of withdrawals, adverse events (AEs) and 
      monitoring of vital signs. RESULTS: The number of patient withdrawals was low: 3 
      of 27 in OD1, 1 of 25 in OD3 and 2 of 26 in BID3. One or more AEs were reported 
      in 9 patients in OD1, 7 patients in OD3 and 12 patients in BID3. Most AEs were 
      mild or moderate, and typical for the population studied; no clinically important 
      differences in AEs or vital signs were observed between the different dosing 
      schedules. There were no between-group differences in efficacy, as assessed by 
      clinical global severity and clinical global change. These results are consistent 
      with the good safety profile of memantine observed in larger studies. 
      CONCLUSIONS: Although relatively small in size, the study indicates that 
      once-daily dosing and twice-daily dosing of memantine are similar in terms of 
      safety and tolerability.
CI  - (c) 2006 John Wiley & Sons, Ltd.
FAU - Jones, Roy W
AU  - Jones RW
AD  - Research Institute for the Care of the Elderly (RICE), Bath, UK. 
      R.W.Jones@bath.ac.uk
FAU - Bayer, Antony
AU  - Bayer A
FAU - Inglis, Fraser
AU  - Inglis F
FAU - Barker, Andrew
AU  - Barker A
FAU - Phul, Ravinder
AU  - Phul R
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int J Geriatr Psychiatry
JT  - International journal of geriatric psychiatry
JID - 8710629
RN  - 0 (Dopamine Agents)
RN  - W8O17SJF3T (Memantine)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy
MH  - Anxiety/chemically induced
MH  - Dopamine Agents/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Least-Squares Analysis
MH  - Male
MH  - Memantine/*administration & dosage/adverse effects
MH  - Mental Disorders/chemically induced
MH  - Neuropsychological Tests
MH  - Patient Selection
MH  - Safety
MH  - Treatment Outcome
EDAT- 2007/01/24 09:00
MHDA- 2008/01/11 09:00
CRDT- 2007/01/24 09:00
PHST- 2007/01/24 09:00 [pubmed]
PHST- 2008/01/11 09:00 [medline]
PHST- 2007/01/24 09:00 [entrez]
AID - 10.1002/gps.1752 [doi]
PST - ppublish
SO  - Int J Geriatr Psychiatry. 2007 Mar;22(3):258-62. doi: 10.1002/gps.1752.