Acute response to cholinergic challenge predicts long-term response to
galantamine treatment in patients with Alzheimer's Disease
Abstract
Cholinesterase inhibitors have been shown to improve cognitive
functioning in patients with Alzheimer’s Disease (AD), but are
associated with side effects and only 20-40% of the patients clinically
improve. In this study, we aimed to investigate the acute
pharmacodynamic (PD) effects of a single dose of galantamine on CNS
functioning in mild to moderate AD patients and its potential to predict
long-term treatment response. This study consisted of a challenge phase,
in which a single dose of 16 mg galantamine was administered to 50 mild
to moderate AD patients in a double-blind, placebo-controlled cross-over
fashion. Acute PD effects were monitored with use of a CNS test battery.
In the subsequent treatment phase of the study, patients were treated
with open-label galantamine according to regular care. After 6 months of
galantamine treatment, patients were categorized as either responder or
as non-responder based on their MMSE, NPI and DAD scores. An analysis of
covariance was performed to study the difference in acute PD effects
between responders and non-responders. Acute decreases of absolute
frontal alpha (-20.4; 95%CI=-31.6,-7.47; p=.0046), beta (-15.7; 95%
CI=-28.3,-0.93; p=.0390) and theta (-25.9; 95%CI=-38.4,-10.9; p=.0024)
EEG parameters and of relative frontal theta power (-3.27%;
95%CI=-5.96,-0.58; p=.0187) on EEG after a single dose administration
of galantamine significantly distinguished long-term treatment
responders (n=11) from non-responders (n=32) after 6 months. This study
demonstrates that patients who demonstrate a reduction in EEG power in
the alpha and theta frequency after a single administration of
galantamine 16 mg will most likely respond to treatment.