Bupropion for the Treatment of Apathy in Alzheimer's Dementia

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.

Conditions

• Apathy in Dementia

Interventions

DRUG

Elontril

flexible dose of Bupropion 150-300 mg

DRUG

placebo

Sponsors & Collaborators

• University of Cologne

  collaborator OTHER

• Physician of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Universität Duisburg-Essen

  collaborator OTHER

• University of Erlangen-Nürnberg

  collaborator OTHER

• University of Freiburg

  collaborator OTHER

• University Medical Center Goettingen

  collaborator OTHER

• Universität des Saarlandes

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Rostock

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• University Hospital, Bonn

  lead OTHER

Principal Investigators

• Frank Jessen, MD · University Bonn

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• Germany

Study Locations