Apathy in Dementia Clinical Trial
Official title:
A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Bupropion for the Treatment of Apathy in Alzheimer's Dementia(Apa-AD)
Apathy in dementia prevents successful application of non-pharmacological treatments,
accelerates cognitive and functional decline and increases disease-related costs by earlier
need for full-time care. Apathy is a distinct entity and occurs independently of other
neuropsychiatric syndromes, like depression.
Today, there is no high-level evidence for any effective treatment of apathy in AD. In
contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and
despite its high prevalence and clinical relevance, apathy has never been the primary
outcome in a clinical trial. Basic and clinical research has provided a distinct model of
the pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter
systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake
inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients
with organic brain disorders. This study will test the efficacy and safety of Bupropion in
the treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial.
Secondary endpoints will be quality of life of patients, caregivers' distress, ability of
patients to perform activities of daily living,utilization of healthcare resources by
patients and by caregivers, and cognitive functions.
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