Bupropion for the Treatment of Apathy in Alzheimer's Dementia
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Bonn
Collaborators:
Charite University, Berlin, Germany Heidelberg University Johannes Gutenberg University Mainz Ludwig-Maximilians - University of Munich Philipps University Marburg Medical Center Physician of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef Saarland University Universität des Saarlandes Universität Duisburg-Essen University Hospital Tuebingen University Medical Center Goettingen University of Cologne University of Erlangen-Nürnberg University of Freiburg University of Rostock University of Ulm