Efficacy and safety of galantamine in patients with dementia with Lewy bodies: a 24-week open-label study.
BACKGROUND
Dementia with Lewy bodies (DLB) is a common dementia of the elderly. A significant cholinergic deficit has been demonstrated that may be responsive to treatment by cholinesterase inhibitors (ChEIs).


METHODS
A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB.


RESULTS
This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. Adverse events were generally mild and transient.


CONCLUSIONS
Galantamine appears to be an effective and safe therapy for patients with DLB.
Edwards
Keith
K
Alzheimer's Diagnostic and Treatment Center, Bennington, VT 05201, USA. kedwards@vtneuro.com
Royall
Donald
D
Hershey
Linda
L
Lichter
David
D
Hake
Ann
A
Farlow
Martin
M
Pasquier
Florence
F
Johnson
Stewart
S
D000368:Aged; D000369:Aged, 80 and over; D001526:Behavioral Symptoms / Q000188:drug therapy / Q000209:etiology; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D003704:Dementia / Q000150:complications / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005702:Galantamine / Q000008:administration & dosage / Q000627:therapeutic use*; D006212:Hallucinations / Q000150:complications / Q000188:drug therapy; D006801:Humans; D020961:Lewy Body Disease / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D009460:Neurologic Examination; D009483:Neuropsychological Tests; D020734:Parkinsonian Disorders / Q000150:complications / Q000188:drug therapy; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D005702:Galantamine