EEG-cholinergic Index and Its Validation of Clinical Response to Treatment With Cholinesterase Inhibitors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 218
- 主要终点
- Change from baseline in Addenbrooke cognitive battery at 3 months and at 6 months
研究概览
简要总结
Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been made. Nevertheless, it has been shown in several studies that up to 30% of patients do not benefit from treatment. These drugs can have side effects, most frequently from the gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most frequent signs. It is therefore important to know before the treatment is initiated if the patient will likely benefit from the drug or not. It is not possible today with current knowledge but this project aims to evaluate a specific index, calculated from an EEG registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration is done before treatment and the cholinergic index calculated from the EEG registration is compared to the clinical outcome. The duration of follow up is 6 months with an extension of further 6 months.
详细描述
Patients will be recruited in a Memory Clinic. Three possible groups of participants will be offered participation:
- Those with Mild Cognitive Impairment (MCI) but with biomarkers of Alzheimer´s disease (AD) that are conclusive enough to lead to the diagnosis of AD and to initiate medical treatment.
- Those with early dementia of AD that are offered medical treatment and are able to give consent.
- Those with early dementia of Lewy body dementia or Parkinson dementia that are offered medical treatment.
All eligible participants are evaluated by the Mini Mental State Examination (MMSE), Consortium to Establish Registry in Alzheimer´s Disease (CERAD 10 word test; working memory, delayed memory and recognition) and Clock Drawing Test (CDT). In addition, the Addenbrooke test will be used.
Patients with AD irrespective of stage will be offered treatment with donepezil, the most used and cheapest cholinesterase inhibitor in Iceland. The dosis will be as usual, 5mg in the evening for four weeks, then increased to 10mg in the evening.
Patients with Lewy body dementia and Parkinson dementia are offered rivastigmine in patch as this is the only medication with the indication of cognitive impairment in these disorders. The starting dose is 4.6mg/day increased to 9.5mg/day after 4 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease.
排除标准
- •Too advanced dementia (5 or more on Global Deterioration Scale)
- •likelihood of poor compliance due to social circumstances, drug or alcohol abuse or other defined causes.
结局指标
主要结局
Change from baseline in Addenbrooke cognitive battery at 3 months and at 6 months
时间窗: Baseline, 3 months, 6 months
Addenbrooke cognitive battery will be used before initiating treatment (baseline), after 3 months and after 6 months
次要结局
- Mini Mental State Examination (MMSE)(Baseline, 3 months, 6 months)
- CERAD-10 word test(Baseline, 3 months, 6 months)