NCT00191009已完成2 期
Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- To see if Alzheimer's patients receiving a stable dose of an Alzheimer's drug randomly assigned to atomoxetine for approximately 6 months will have cognitive performance improved as measured by the Alzheimer's Disease Assessment Scale - Cognitive
研究概览
简要总结
This study will compare atomoxetine to placebo when taken with current standard Alzheimer's Disease medications. The treatment will take approximately 6 months and it is hypothesized atomoxetine will significantly improve cognitive performance as compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents with Alzheimer's Disease based on clinical history.
- •Patient must have a Mini Mental Status Score between 10 and
- •Patient must have a reliable caregiver in frequent or daily contact with the patient.
- •Patient must be currently treated with and on a stable dose of a standard Alzheimer's drug treatment for at least 3 months.
排除标准
- •Patients who are receiving pharmacologic treatments (other than a cholinesterase inhibitor or memantine) for Alzheimer's Disease.
- •Patients who have a history in the past 5 years or any current evidence of major psychiatric illness.
- •Patients who have narrow angle glaucoma.
- •Patients who are experiencing clinically significant urinary hesitancy or retention as assessed by a physician.
结局指标
主要结局
To see if Alzheimer's patients receiving a stable dose of an Alzheimer's drug randomly assigned to atomoxetine for approximately 6 months will have cognitive performance improved as measured by the Alzheimer's Disease Assessment Scale - Cognitive
次要结局
- To see if patients taking an Alzheimer's medication plus atomoxetine for approximately 6 months will be superior to an Alzheimer's medication alone as assessed by the Clinician's Interview-Based Impression of Change (CIBIC+) score.
- To see if patients taking an Alzheimer's medication plus atomoxetine will display less comorbid psychological symptoms, such as depression, as assessed by the Neuropsychiatric Inventory (NPI). Patients will receive the NPI once before randomization
- To see if current Alzheimer's medications plus atomoxetine compared to Alzheimer's medications plus placebo is better at preserving or slowing cognitive decline as measured by the Alzheimer's Disease Cooperative Study Inventory - Activities of
- To show that current Alzheimer's drugs can be taken with atomoxetine without significant side effects.
研究者
研究点 (3)
Loading locations...
相似试验
撤回
3 期
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late EffectsCognitive Late EffectsCancerNCT00255138Temple University
已完成
4 期
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum DisorderAutistic DisorderAttention Deficit Disorder With HyperactivityNCT00380692Eli Lilly and Company97
已完成
2 期
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety DisorderGeneralized Social PhobiaNCT00260533University of California, San Diego27
已完成
4 期
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety DisorderComorbid Social Anxiety DisorderAttention Deficit Hyperactivity DisorderNCT00190879Eli Lilly and Company440
已完成
4 期
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)Reading DisorderAttention Deficit Hyperactivity DisorderNCT00191906Eli Lilly and Company121