Bupropion for the Treatment of Apathy in Alzheimer's Dementia

NCT01047254 | Completed Phase 3 DMC

• 1 other identifier: 2007-005352-17
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Apathy Evaluation Scale (AES) score

  12 weeks

Secondary Outcomes (1)

• NPI total score;NPI caregivers' distress total score;ADCS-ADL; QoL-AD; RUD;ADAScog;MMSE

  12 weeks

Study Arms (2)

Bupropion

ACTIVE COMPARATOR

Buproprion 150-300 mg in a flexible dose

Drug: Elontril

placebo capsule

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Elontril DRUG

flexible dose of Bupropion 150-300 mg

Bupropion

placebo DRUG

placebo capsule

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bonn: lead
• University of Cologne: collaborator
• Physician of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef: collaborator
• Charite University, Berlin, Germany: collaborator
• Universität Duisburg-Essen: collaborator
• University of Erlangen-Nürnberg: collaborator
• University of Freiburg: collaborator
• University Medical Center Goettingen: collaborator
• Universität des Saarlandes: collaborator
• Johannes Gutenberg University Mainz: collaborator
• Heidelberg University: collaborator
• Philipps University Marburg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University of Rostock: collaborator
• University Hospital Tuebingen: collaborator
• University of Ulm: collaborator

Study Sites (1)

Department of Psychiatry, University Bonn

Bonn, 53105, Germany

Location

Study Officials

• Frank Jessen, MD

  University Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

DE (1)