Bupropion for the Treatment of Apathy in Alzheimer's Dementia (APA-AD)
This study is currently recruiting participants.
Verified July 2010 by University Hospital, Bonn
Sponsor:
University Hospital, Bonn
Collaborators:
Center for Clinical Trials ZKS Cologne
Physician's office of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef
Department of Psychiatry Charite Campus Benjamin Franklin Berlin
Department of Psychiatry Charite Campus Mitte Berlin
Universität Duisburg-Essen
University of Erlangen-Nürnberg
University of Freiburg
University Medical Center of Göttingen
Saarland University
Studycentre of mental disorders, University Mainz
University of Heidelberg
Clinic of Neurology, University Marburg
Ludwig-Maximilians - University of Munich
University of Rostock
University Hospital Tuebingen
University of Ulm
Information provided by (Responsible Party):
Frank Jessen, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01047254
First received: January 11, 2010
Last updated: December 20, 2012
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Apathy in Dementia |
Drug: Elontril Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bonn:
Primary Outcome Measures:
- Change in Apathy Evaluation Scale (AES) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- NPI total score;NPI caregivers' distress total score;ADCS-ADL; QoL-AD; RUD;ADAScog;MMSE [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 216 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bupropion
Buproprion 150-300 mg in a flexible dose
|
Drug: Elontril
flexible dose of Bupropion 150-300 mg
|
|
Placebo Comparator: placebo capsule
Placebo
|
Drug: placebo |
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mild to moderate Alzheimer's dementia, male and female (NINCDS/ADRDA criteria)
- Presence of clinically relevant apathy defined by the Neuropsychiatric Inventory (NPI) apathy item (score of >/= 4 points) and the Marin/Starkstein criteria for apathy
- MMSE: 10-25
- Outpatient status, not institutionalized
- Presence of reliable caregiver
- Stable treatment with antidementia drugs for at least three months prior to entry or no treatment with antidementia drugs
Exclusion Criteria:
- Other Dementia (e.g. vascular dementia, Lewy-body dementia, fronto-temporal dementia)
- Presence of a clinically relevant depression defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood)
- Alcoholism and Benzodiazepine addiction
- Current treatment with antipsychotics and antidepressants (including St. John's wart)
- Current treatment with dopaminergic agents or Amantadin
- Current treatment with benzodiazepines
- Current treatment with MAO inhibitor (Bupropion contraindication)
- Known sensibility to Bupropion treatment
- Severe psychiatric disease (including hospitalization) in the last 6 months, suicide attempt, acute psychotic symptoms
- Severe physical illness, that do not allow a participation in a 12-week period of treatment
- Medical history with seizures
- Medical history with tumors of the central nervous system
- Severe craniocerebral injury and medical history with cerebral substance defect
- Clinically relevant renal disease, liver insufficiency
- Simultaneous treatment, which reduces the seizure threshold (e.g. antipsychotics, antidepressants, antimalarial agents, Tramadol, Theophyllin, systemic steroids in higher dose, Chinolone, sedative antihistamines)
- Simultaneous treatment, which is metabolized through Cytochrom P450-Isoenzym 2D6 (e.g. these beta blockers: Metoprolol, Proanolol, Timolol, Carvediol, Nebivolol, Typ-1C-Antiarrhyhtmics for e.g. Propafenon, Flecinid) (except Donepezil and Galantamin)
- Simultaneous treatment with drugs, which may interfere with the metabolization of Bupropion (e.g. Carbamazepin, Phenytoin, Valproat, Ritonavir, Lopinavir)
- Diabetes mellitus, which is therapeutically poorly regulated and treated by medication
- Treatment with stimulants and appetite depressants
- Participation in other clinical trials with in the last 3 months
- Suicidal tendency
- Known lactose intolerance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047254
Contacts
| Contact: Annika Spottke, MD | +49 228 287 15712 | annika.spottke@ukb.uni-bonn.de |
Locations
| Germany | |
| Department of Psychiatry, University Bonn | Recruiting |
| Bonn, Germany, 53105 | |
| Principal Investigator: Frank Jessen, MD | |
Sponsors and Collaborators
University Hospital, Bonn
Center for Clinical Trials ZKS Cologne
Physician's office of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef
Department of Psychiatry Charite Campus Benjamin Franklin Berlin
Department of Psychiatry Charite Campus Mitte Berlin
Universität Duisburg-Essen
University of Erlangen-Nürnberg
University of Freiburg
University Medical Center of Göttingen
Saarland University
Studycentre of mental disorders, University Mainz
University of Heidelberg
Clinic of Neurology, University Marburg
Ludwig-Maximilians - University of Munich
University of Rostock
University Hospital Tuebingen
University of Ulm
Investigators
| Principal Investigator: | Frank Jessen, MD | University Bonn |
More Information
No publications provided
| Responsible Party: | Frank Jessen, Prof. Dr., University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT01047254 History of Changes |
| Other Study ID Numbers: | 2007-005352-17 |
| Study First Received: | January 11, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Bupropion Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013