Apathy in Alzheimer's Disease MedDRA version: 14.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Elontril ®
Product Name: BUPROPION HYDROCHLORIDE
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: BUPROPION HYDROCHLORIDE
CAS Number: 31677-93-7
Concentration unit: mg m
Sponsors
University Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: • Mild to moderate Alzheimer’s dementia, male and femal(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 months Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: Key exclusion criteria: • Presence of a clinically relevant depressed mood defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood) • Treatment with antipsychotics (may interfere with the Bupropion mechanism of action) • Treatment with antidepressants (may interfere with the Bupropion mechanisms of action) • Treatment with dopaminergic agents (may interfere with the Bupropion mechanism of action) • Treatment with MAO inhibitor (Bupropion contraindication) • Other contraindications to Bupropion treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of Bupropion in the treatment of apathy in Alzheimer’s dementia. Primary hypothesis: Bupropion reduces the score on the Apathy Evaluation Scale (AES) as compared to a placebo group in Alzheimer’s dementia patients with apathy.;Secondary Objective: Secondary hypotheses (to be evaluated by means of exploratory statistical methods): Bupropion compared with placebo treatment (1) improves overall neuropsychiatric syndromes, (2) reduces caregivers’ distress related to neuropsychiatric syndromes, (3) improves the patients’ ability to perform activities of daily living, (4) improves quality of life of patients, (5) reduced utilization of healthcare resources by patients and by caregivers, (6) improves cognition of patients.;Primary end point(s): Change in Apathy Evaluation Scale (AES) score 12 weeks after randomization;Timepoint(s) of evaluation of this end point: After week 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life, cognition and activities of daily living;Timepoint(s) of evaluation of this end point: After week 4, 8 and 12 | — |
Countries
Germany
Contacts
Public ContactKBFZ
University Bonn
Outcome results
None listed