Lewy Body Spectrum Disorders: Investigating Neuropsychiatric Benefit and Adverse Effects in Response to Cholinesterase Inhibitors Using Genetics and Brain SPECT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change from baseline in neuropsychological assessment scores at 6 months
研究概览
简要总结
Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause memory loss, behavioural and motor disabilities that impair quality of life. Cognitive enhancers help people afflicted with these conditions. However, some people do not benefit from this treatment, while others experience serious side effects. Side effects and poor response lead to hospitalization and early institutionalization. Pharmacogenomics, the study of how DNA variation can influence drug effects, will be combined with functional changes in brain imaging in response to cognitive enhancers in patients with Lewy body disease. The goal is to develop a predictive test that can be administered in the clinic to aid physicians' choice of initial medication. This can reduce health care costs and improve treatment to Canadians suffering from these devastating disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Inclusion criteria for patients with a Lewy body spectrum disorder includes: age > 50 years; and mild-moderate dementia (Mini-Mental State Exam [MMSE] > 9); contact on at least four of seven days/week with a responsible caregiver; Hoehn & Yahr stage ≤ 4.
排除标准
- •age < 50; Severe dementia (MMSE < 9); contact < 4 days a week with a responsible caregiver; Hoehn & Yahr stage > 4.
研究组 & 干预措施
Parkinson's Disease Dementia
Participants in the Parkinson's Disease Dementia group:
- Must be taking a stable parkinsonian medication
- Must have a diagnosis of clinically definite Parkinson's disease >1 year prior to cognitive deficit with at least two of the following symptoms: asymmetric resting tremor, rigidity or bradykinesia, and definite motor response to dopaminergic agents.
- Response to cholinesterase inhibitor over a period of six months will be monitored.
干预措施: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine) (Drug)
Dementia with Lewy Bodies
Participants in the Dementia with Lewy Bodies group:
- Diagnosis of clinically probable or possible Dementia with Lewy bodies with at least 1 of the following: Marked fluctuations in cognition, visual hallucinations or spontaneous parkinsonism.
- Response to cholinesterase inhibitor over a period of six months will be monitored.
干预措施: Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine) (Drug)
结局指标
主要结局
Change from baseline in neuropsychological assessment scores at 6 months
时间窗: 0 and 6 months
Change from baseline in perfusion brain SPECT at 6 months
时间窗: 0 and 6 months
次要结局
- Volumetric Brain MRI(Baseline)
研究者
Dr. Mario Masellis
Clinician-Scientist
Sunnybrook Health Sciences Centre