Trial of Propranolol in Older Adults With Primary Progressive Aphasia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neuropsychological Assessment Battery Naming Test
研究概览
简要总结
The purpose of this study is to find out how the language of people with Primary Progressive Aphasia is affected by Propranolol. Propranolol is not FDA approved for the treatment of Primary Progressive Aphasia. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure.
This research is being done because there are currently no drug treatment options for language impairments and anxiety often experienced by people with Primary Progressive Aphasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age: 50 and older
- •2. Primary Progressive Aphasia diagnosis
- •3. Native English speaker
排除标准
- •1. Unable to provide consent
- •2. Taking alpha 2 agonists (clonidine and guanfacine)
- •3. Other major psychological or neurological diagnosis
- •4. Major head trauma that contributed to their condition
- •5. Allergic reaction to adhesives
- •6. Uncorrected vision/hearing impairments
- •7. Diabetes
- •8. Reactive airway disease
- •9. Untreated hypothyroidism
- •10. Bradyarrhythmia
- •11. Unexplained syncope
- •12. Pregnancy (assessed verbally on the days of MR imaging)
- •13. Drugs that interact with propranolol, such as alpha 2 agonists
- •14. Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
研究组 & 干预措施
Propanolol and MRI
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
干预措施: Propranolol (Drug)
Placebo and MRI
Participants will receive placebo via oral capsule.
干预措施: Placebo (Drug)
Propanolol and MRI
Participants will receive propranolol via oral capsule. The drug dosage will be titrated slowly to ensure the drug is tolerated well.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
Placebo and MRI
Participants will receive placebo via oral capsule.
干预措施: Magnetic Resonance Imaging (MRI) (Device)
结局指标
主要结局
Change in Neuropsychological Assessment Battery Naming Test
时间窗: Day 1, 4 Weeks, 8 Weeks, 10 Weeks, 14 Weeks,18 Weeks
次要结局
- Change in State-Trait Anxiety Inventory for Adults(Day 1, 4 Weeks, 8 Weeks, 10 Weeks,14 Weeks,18 Weeks)
- Change in Semantic Word Fluency Tasks(Day 1, 8 Weeks,18 Weeks)
研究者
David Beversdorf
Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri-Columbia
University of Missouri-Columbia