DRKS00000103已完成3 期
A 12-week, multicenter, randomized, double-blind, placebo-controlled trial of Bupropion for the treatment of apathy in Alzheimer's Dementia - Apa-AD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 90 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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