PMID- 18631948 OWN - NLM STAT- MEDLINE DCOM- 20080826 LR - 20131121 IS - 1552-5279 (Electronic) IS - 1552-5260 (Linking) VI - 4 IP - 1 DP - 2008 Jan TI - One-week dose titration of extended release galantamine in patients with Alzheimer's disease. PG - 30-7 LID - 10.1016/j.jalz.2007.10.013 [doi] AB - BACKGROUND: Our purpose was to assess the safety and tolerability of extended-release galantamine (GAL-ER), using a 1-week dose titration in Alzheimer's patients. METHODS: An open-label, 12-week, multicenter study was performed (n = 82). Results were compared with findings from a placebo-controlled trial using a 4-week titration of GAL-ER and immediate-release galantamine. The primary analysis compared incidences of adverse events (AEs). RESULTS: Although not statistically significant, more patients in the 1-week titration study experienced an AE. More patients with a 1-week titration had at least one prespecified gastrointestinal (GI) AE. These findings correlated with a higher baseline incidence of GI disturbances. Four patients experienced serious AEs; no deaths occurred. Mean Mini-Mental State Examination scores improved by 1.8 and 1.9 points at weeks 4 and 12, respectively. CONCLUSIONS: A 1-week titration of GAL-ER was generally safe and well tolerated, with a potential risk of more GI side effects. A 1-week titration may permit dosing flexibility and promote increased adherence to medication regimens. FAU - Scharre, Douglas W AU - Scharre DW AD - Division of Cognitive Neurology, Department of Neurology, Ohio State University, Columbus, OH, USA. FAU - Shiovitz, Thomas AU - Shiovitz T FAU - Zhu, Young AU - Zhu Y FAU - Amatniek, Joan AU - Amatniek J LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20071221 PL - United States TA - Alzheimers Dement JT - Alzheimer's & dementia : the journal of the Alzheimer's Association JID - 101231978 RN - 0 (Cholinesterase Inhibitors) RN - 0D3Q044KCA (Galantamine) SB - IM MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy MH - Cholinesterase Inhibitors/*administration & dosage/adverse effects MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Female MH - Galantamine/*administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged EDAT- 2008/07/18 09:00 MHDA- 2008/08/30 09:00 CRDT- 2008/07/18 09:00 PHST- 2007/04/17 00:00 [received] PHST- 2007/09/11 00:00 [revised] PHST- 2007/10/25 00:00 [accepted] PHST- 2008/07/18 09:00 [pubmed] PHST- 2008/08/30 09:00 [medline] PHST- 2008/07/18 09:00 [entrez] AID - S1552-5260(07)00638-3 [pii] AID - 10.1016/j.jalz.2007.10.013 [doi] PST - ppublish SO - Alzheimers Dement. 2008 Jan;4(1):30-7. doi: 10.1016/j.jalz.2007.10.013. Epub 2007 Dec 21.