Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial.
BACKGROUND
Vascular dementia is the second commonest form of dementia, and vascular factors contribute to the development of dementia in many patients with Alzheimer's disease. Galantamine amplifies the acetylcholine response by inhibiting acetylcholinesterase and modulating nicotinic receptors. It has shown broad, sustained benefits in patients with Alzheimer's disease. We investigated the effects of galantamine in patients with a diagnosis of probable vascular dementia or Alzheimer's disease combined with cerebrovascular disease.


METHODS
Eligible patients were randomly assigned galantamine 24 mg/day (n=396) or placebo (n=196) in a multicentre, double-blind, 6-month trial. Primary endpoints were cognition (Alzheimer's disease assessment scale, cognitive subscale [ADAS-cog]) and global functioning (clinician's interview-based impression of change plus caregiver input [CIBIC-plus]). Secondary endpoints included assessments of activities of daily living and behavioural symptoms. Patients were monitored for adverse events. Analyses were on the basis of observed case or last observation carried forward.


RESULTS
Galantamine showed greater efficacy than placebo on ADAS-cog (galantamine change -1.7 [SE 0.4] vs placebo 1.0 [0.5]; treatment effect 2.7 points; p<0.0001) and CIBIC-plus (213 [74%] vs 95 [59%] patients remained stable or improved, p=0.0001). Activities of daily living and behavioural symptoms were also significantly improved compared with placebo (p=0.002 and p=0.016, respectively). Galantamine was well tolerated.


CONCLUSIONS
Galantamine showed a therapeutic effect on all key areas of cognitive and non-cognitive abilities in this group of dementia patients.
Erkinjuntti
Timo
T
Department of Clinical Neurosciences, Helsinki University Central Hospital, Helsinki, Finland. timo.erkinjuntti@hus.fi
Kurz
Alexander
A
Gauthier
Serge
S
Bullock
Roger
R
Lilienfeld
Sean
S
Damaraju
ChandrasekharRao Venkata
CV
D000368:Aged; D000544:Alzheimer Disease / Q000150:complications / Q000188:drug therapy*; D002561:Cerebrovascular Disorders / Q000150:complications*; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D015140:Dementia, Vascular / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D005702:Galantamine