title: Efficacy and safety of galantamine in patients with dementia with Lewy bodies: a 12-week interim analysis.
abstract: Observations on the neurochemistry of dementia with Lewy bodies (DLB) have suggested that cholinesterase inhibitors (ChEIs) might be beneficial in treating some clinical symptoms of DLB. A 24-week, multicenter open-label study was designed to assess the safety and efficacy of the ChEI galantamine in patients with DLB, and an interim analysis of results was performed at 12 weeks. Efficacy analyses were performed on data from 25 patients. Scores on the Neuropsychiatric Inventory (NPI-12) improved (decreased) by 7.52 points over the 12 weeks (marginally significant, p = 0.061). NPI-12 scores decreased by half in 12 of the 25 patients. Highly significant improvement was observed in scores on the NPI-4 subscale (delusions, hallucinations, apathy, and depression: p = 0.003). Scores on the Clinician's Global Impression of Change (CGIC) improved by 0.95 points (significant, p = 0.02). Improvements also were found in secondary efficacy variables, including cognitive, functional, activities of daily living, sleep and confusion assessments. Motor scores, as measured by the UPDRS motor subscale, showed mild improvement, which demonstrates that galantamine has no adverse effect on parkinsonian symptoms. Adverse events generally were transient and of mild-to-moderate intensity. Two of the 25 patients discontinued galantamine because of nausea and anorexia. One serious adverse event was recorded, but it was judged to be unrelated to the study medication.
authors.affiliation: Alzheimer's Diagnostic and Treatment Center, Neurological Research Center, Bennington, Vt. 05201, USA. kedwards@vtneuro.com
authors.forename: Keith R
authors.initials: KR
authors.lastname: Edwards
authors.forename: Linda
authors.initials: L
authors.lastname: Hershey
authors.forename: Laura
authors.initials: L
authors.lastname: Wray
authors.forename: Edward M
authors.initials: EM
authors.lastname: Bednarczyk
authors.forename: David
authors.initials: D
authors.lastname: Lichter
authors.forename: Martin
authors.initials: M
authors.lastname: Farlow
authors.forename: Stewart
authors.initials: S
authors.lastname: Johnson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005702:Galantamine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D020961:Lewy Body Disease / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D009460:Neurologic Examination / Q000187:drug effects; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014529:Uridine / Q000031:analogs & derivatives*
chemical_list: D002800:Cholinesterase Inhibitors; D018697:Nootropic Agents; D005702:Galantamine; C053196:5'-O-(L-valyl)-5-fluorouridine hydrochloride; D014529:Uridine