Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low dose of ORM-12741
干预措施: ORM-12741 (Drug)
High dose of ORM-12741
干预措施: ORM-12741 (Drug)
Placebo
干预措施: Placebo for ORM-12741 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 3 months
Adverse events from start of ORM-12741 treatment until end of study visit.
Quality of Working Memory
时间窗: 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.
Quality of Memory
时间窗: 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.
Power of Attention
时间窗: 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.
Quality of Episodic Memory
时间窗: 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.
Continuity of Attention
时间窗: 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.
Speed of Memory
时间窗: 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.
次要结局
- NPI Total Score(3 months)
- Pharmacokinetics of ORM-12741(3 months)
- Caregiver Distress Score(3 months)