Galantamine treatment of vascular dementia: a randomized trial.
BACKGROUND
To evaluate efficacy and safety of galantamine for patients with vascular dementia (VaD).


METHODS
In this multinational, randomized, double-blind, placebo-controlled, parallel-group clinical trial, 788 patients with probable VaD who also satisfied strict centrally read MRI criteria were randomized to receive galantamine or placebo. Efficacy was evaluated using measures of cognition, daily function, and behavior. The primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog/11) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) total score. Secondary outcomes included the Clinician's Interview Based on Impression of Change-Plus Caregiver Input (CIBIC-plus), Neuropsychiatric Inventory, and EXIT-25 for assessment of executive functioning. Safety and tolerability were also monitored.


RESULTS
Patients treated with galantamine had a greater improvement in ADAS-cog/11 after 26 weeks compared with placebo (-1.8 vs -0.3; p < 0.001). There was no difference between galantamine and placebo at week 26 on the ADCS-ADL score (0.7 vs 1.3; p = 0.783). Improvement in global functioning measured by the CIBIC-plus associated with galantamine approached significance (p = 0.069). A difference between treatment groups for EXIT-25 favoring galantamine was detected (p = 0.041). Safety data revealed that 13% of galantamine and 6% of placebo patients discontinued treatment because of adverse events.


CONCLUSIONS
Significance was not reached for both co-primary endpoints. Galantamine was effective for improving cognition, including executive function, in patients with vascular dementia, with good safety and tolerability. However, improvement in activities of daily living with galantamine was similar to that observed with placebo.
University of Tennessee Health Science Center, Department of Neurology, Memphis, TN 38163, USA. aauchus@utmem.edu
A P
AP
Auchus
H R
HR
Brashear
S
S
Salloway
A D
AD
Korczyn
P P
PP
De Deyn
C
C
Gassmann-Mayer
D000109:Acetylcholine / Q000378:metabolism; D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D000368:Aged; D001526:Behavioral Symptoms / Q000188:drug therapy; D001921:Brain / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D001923:Brain Chemistry / Q000187:drug effects / Q000502:physiology; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000188:drug therapy / Q000209:etiology; D015140:Dementia, Vascular / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010919:Placebos; D020127:Recovery of Function / Q000187:drug effects; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D010919:Placebos; D005702:Galantamine; D000109:Acetylcholine