A twelve-week, multicenter, randomized, double-blind, placebo-controlled trail of Bupropion for the treatment of apathy in Alzheimer’s Dementia

INTERVENTION: 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 milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: 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 Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: 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. Primary end point(s): Change in Apathy Evaluation Scale (AES) score 12 weeks after randomization 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. Timepoint(s) of evaluation of this end point: After week 4, 8 and 12 SECONDARY OUTCOME: 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 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