A 12-week, multicenter, randomized, double-blind, placebo-controlled trial of Bupropion for the treatment of apathy in Alzheimer's Dementia

Phase 3

• Conditions: F00; R45.3; Dementia in Alzheimer disease; Demoralization and apathy

• Registration Number: DRKS00000103
• Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-22
• Study Completion: 2014-07-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 140

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
Age: 55-90
Outpatient status, not institutionalized
Presence of reliable caregiver
Stable treatment with antidementia drugs for at least three month

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Apathy Evaluation Scale (AES) score 12 weeks after randomization

Secondary Outcome Measures

Name	Time	Method
(1) Change in Neuropsychiatric Inventory (NPI) total score;<br>(2) Change in the NPI caregivers' distress total score;<br>(3) Change in the AD Cooperative Study Activities of Daily Living Scale (ADCS-ADL score); <br>(4) Change in the Quality of Life-AD scale (QoL-AD); <br>(5) Change in the Resources Utilization in Dementia Questionaire (RUD); <br>(6) Change in Alzheimer's Disease Assessment Scale, cognitive part (ADAScog score); <br>(7) Change in Mini-Mental Status Examination (MMSE) score