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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT01047254
Study type Interventional
Source University Hospital, Bonn
Contact
Status Completed
Phase Phase 3
Start date January 2010
Completion date July 2014

See also
  Status Clinical Trial Phase
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Recruiting NCT04958031 - A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy Phase 2
Recruiting NCT06047522 - Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders N/A
Recruiting NCT05561205 - rTMS for Apathy Clinical Trial N/A