Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease (ALPO)
2021年4月1日 更新者：Orion Corporation, Orion Pharma
Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
研究概览
详细说明
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.
研究类型
介入性
注册 (实际的)
100
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Turku、芬兰、20520
- Clinical Research Services Turku (CRST)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Informed consent obtained from the patient and legally acceptable representative, if required
- Informed consent obtained from the caregiver
- Males and and females between 55-90 years
- Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration
- Brain imaging consistent with Alzheimer's disease
- Mini-mental state examination score 12-21
- Treated with donepezil, rivastigmine or galantamine
- At least mild level of behavioral symptoms
Exclusion Criteria:
- Other types of dementias
- Modified Hachinski Ischemia Score > 4
- Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months
- Changes in antidepressant dosing within 2 months
- Use of other psychotropic agents
- Myocardial infarction within the past 2 years
- Malignancy within the past 5 years
- Suicidal ideation, risk of suicide
- History of alcoholism or drug abuse within 5 years
- Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness
- Specific findings in brain imaging
- Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension
- Blood donation or participation in a drug study within 60 days
- Previous AD immunotherapy treatment
- Patient cannot complete the computerised cognitive training
- Patients who reside in a skilled nursing facility
- Patients who are not able to swallow capsules
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Placebo twice a day
|
|
实验性的：Low dose of ORM-12741
|
60mg twice a day
200mg twice a day
|
|
实验性的：High dose of ORM-12741
|
60mg twice a day
200mg twice a day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Adverse Events
大体时间：3 months
|
Adverse events from start of ORM-12741 treatment until end of study visit.
|
3 months
|
|
Quality of Episodic Memory
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
|
Quality of Working Memory
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Working Memory measures the capability of maintaining information in working memory and is assessed as the sum of sensitivity indices from 2 memory tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
|
Quality of Memory
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Memory is a combination of outcome measures Quality of Working Memory & Quality of Episodic Memory.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
|
Speed of Memory
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
|
Power of Attention
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
|
Continuity of Attention
大体时间：3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
NPI Total Score
大体时间：3 months
|
The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview.
10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour.
Higher scores mean worse outcome.
Minimum value 0, maximum value 120.
|
3 months
|
|
Caregiver Distress Score
大体时间：3 months
|
Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI.
Higher scores mean worse outcome.
Minimum value 0, maximum value 120.
|
3 months
|
|
Pharmacokinetics of ORM-12741
大体时间：3 months
|
ORM-12741 plasma trough concentrations at week 12.
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Juha Rinne, Prof、Clinical Research Services Turku (CRST)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年4月1日
初级完成 (实际的)
2012年9月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2011年3月24日
首先提交符合 QC 标准的
2011年3月25日
首次发布 (估计)
2011年3月29日
研究记录更新
最后更新发布 (实际的)
2021年4月28日
上次提交的符合 QC 标准的更新
2021年4月1日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.