PMID- 25713600
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150225
LR  - 20220331
IS  - 1758-9193 (Print)
IS  - 1758-9193 (Electronic)
VI  - 7
IP  - 1
DP  - 2015
TI  - Long-term donepezil use for dementia with Lewy bodies: results from an open-label 
      extension of Phase III trial.
PG  - 5
LID - 10.1186/s13195-014-0081-2 [doi]
LID - 5
AB  - INTRODUCTION: The long-term efficacy and safety of donepezil 10 mg in patients 
      with dementia with Lewy bodies (DLB) were investigated in a 52-week Phase 3 
      trial. METHODS: This 52-week study consisted of 16-week randomized 
      placebo-controlled (RCT) and 36-week open-label extension phases. Of 142 DLB 
      patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 
      entered the extension phase. The placebo group of the RCT phase initiated active 
      treatment at week 16, and the active groups maintained allocated treatment and 
      dosages until week 24. After week 24, all patients received 10 mg. Dose reduction 
      to 5 mg for safety concerns was allowed. Efficacy measures included Mini-Mental 
      State Examination (MMSE) for cognitive function and Neuropsychiatric Inventory 
      (NPI) for behavioral symptoms. Safety evaluations included adverse events (AEs) 
      and the unified Parkinson disease rating scale. RESULTS: In total, 100 subjects 
      completed the study. Cognitive function improvement was sustained for 52 weeks 
      (MMSE at week 52 in 10 mg: 2.8 +/- 3.5 (mean +/- standard deviation); P <0.001, 
      Student paired t test)). Those who received placebo in the RCT phase showed an 
      improvement after starting active treatment. NPI improved in all the groups 
      throughout the study, including the placebo period. In the subgroup of the 5 mg 
      group without remarkable cognitive or behavioral improvement at week 24, further 
      improvement was observed after a dose increase to 10 mg. After week 24, 21 
      patients experienced dose reduction. The incidence of any AEs did not increase 
      over time. CONCLUSIONS: The long-term administration of donepezil at 10 mg/day 
      improved cognitive function for up to 52 weeks in patients with DLB without 
      increasing the risk of clinically significant safety events. TRIAL REGISTRATION: 
      NCT01278407. Trial registration date: January 14, 2011.
FAU - Mori, Etsuro
AU  - Mori E
AD  - Department of Behavioral Neurology and Cognitive Neuroscience, Tohoku University 
      Graduate School of Medicine, 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575 
      Japan.
FAU - Ikeda, Manabu
AU  - Ikeda M
AD  - Department of Neuropsychiatry, Faculty of Life Sciences, Kumamoto University, 
      1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556 Japan.
FAU - Nagai, Reiko
AU  - Nagai R
AD  - Eisai Product Creation Systems, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, 
      Tokyo 112-8088 Japan.
FAU - Matsuo, Kazutaka
AU  - Matsuo K
AD  - Eisai Product Creation Systems, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, 
      Tokyo 112-8088 Japan.
FAU - Nakagawa, Masaki
AU  - Nakagawa M
AD  - Eisai Product Creation Systems, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, 
      Tokyo 112-8088 Japan.
FAU - Kosaka, Kenji
AU  - Kosaka K
AD  - Department of Psychiatry, Yokohama City University School of Medicine, 3-9 
      Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004 Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01278407
PT  - Journal Article
DEP - 20150203
PL  - England
TA  - Alzheimers Res Ther
JT  - Alzheimer's research & therapy
JID - 101511643
PMC - PMC4338564
EDAT- 2015/02/26 06:00
MHDA- 2015/02/26 06:01
PMCR- 2015/02/03
CRDT- 2015/02/26 06:00
PHST- 2014/04/28 00:00 [received]
PHST- 2014/10/30 00:00 [accepted]
PHST- 2015/02/26 06:00 [entrez]
PHST- 2015/02/26 06:00 [pubmed]
PHST- 2015/02/26 06:01 [medline]
PHST- 2015/02/03 00:00 [pmc-release]
AID - 81 [pii]
AID - 10.1186/s13195-014-0081-2 [doi]
PST - epublish
SO  - Alzheimers Res Ther. 2015 Feb 3;7(1):5. doi: 10.1186/s13195-014-0081-2. 
      eCollection 2015.