EUCTR2010-022922-34-FI进行中（未招募）不适用
Safety and efficacy of ORM-12741 on cognitive and behavioural symptoms in patients with Alzheimer’s disease: A randomised, double-blind, placebo-controlled, parallel group, multicentre study of 12 weeks - ALPO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients with diagnosis of probable AD, written informed consent (IC) obtained from the subject and/or his/her caregiver. The subject must have a history of progressive cognitive deterioration, brain imaging consistent with AD, at least a mild level of behavioural symptoms present with a neuropsychiatric inventory (NPI) score > 15, mini-mental state examination (MMSE) score 12-21 at screening visit and be treated with donepezil, rivastigmine or galantamine for at least 3 months. The subject must be 55-90 years of age and fulfil all of the inclusion criteria and none of the exclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 99
排除标准
- •1. Any other type of dementia than AD.
- •2. Modified Hachinski Ischemia Score > 4.
- •4. Use of antipsychotics within 2 months prior to screening (even for sleep).
- •5. Use of benzodiazepines, other than short acting sleep medication, for night at a maximum of 3 nights/week, within 2 months prior to screening.
- •6. Use of any anticholinergic medication within 2 months prior to screening (including those used to treat overactive bladder and tricyclic antidepressants).
- •7. Changes in antidepressant dosing during the last 2 months prior to the screening.
- •8. Current use of other psychotropic agents, like antiepileptics or opioid analgesics
- •9. Myocardial infarction within the past 2 years.
- •10. Current or history of malignancy within the past 5 year.
- •11. Suicidal ideation in the 6 months before screening or current suicide risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (items 4 and 5 exclusionary) or current risk of suicide based on the investigator’s judgement.
- •12. Subjects with known or suspected history of alcoholism or drug abuse (within the past 5 years).
- •13. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study.
- •14. Specific findings in MRI that might in the opinion of the investigator affect cognitive function such as cortical infarct, micro-haemorrhage, or silent lacuna (= 1 cm) in a region known to affect cognition such as the hippocampus of either hemisphere, the head of the left caudate, or the dorsomedial region of the left thalamus. With the exception of neuroanatomical areas defined, a maximum of one clinically silent” lacunar infarct is permitted provided the maximal diameter in any dimension is = 1 cm detected on both T1 and T2 weighted MRI images or observed on CT scan images. Multiple white matter lesions consistent with leukoaraiosis are not exclusionary in an otherwise eligible subject.
- •15. Supine HR > 100 bpm after a 5-minute rest at screening visit.
- •16. Supine systolic BP (SPB) > 160 or diastolic BP (DPB) > 100 mmHg after a 5-minute rest at screening visit.
- •17. Symptomatic orthostatic hypotension at screening visit.
- •18. QTc-Fridericia (QTcF) repeatedly > 450 ms in males or > 470 ms in females at screening visit.
- •19. Abnormal thyroid-stimulating hormone (TSH), vitamin B12 or folate serum levels at screening (which can not be corrected with substitute therapy).
- •20. Any other abnormal value in laboratory tests, vital signs or ECG which may in the opinion of the investigator interfere with the interpretation of the study results (e.g. affect cognition) or cause a health risk for the patient if he/she takes part in the study.
- •21. Female patients of childbearing potential (i.e. menstruating or less than 2 years postmenopausal).
- •22. Patients with pre-planned elective surgery.
- •23. Known hypersensitivity to the active substance or to any of the excipients of the study drugs.
- •24. Blood donation or loss of significant amount of blood within 60 days prior to the screening.
- •25. Participation in a drug study within 60 days prior to the screening.
- •26. Previous AD immunotherapy treatment.
- •27. Patient cannot complete the Cognitive Drug Research Ltd. (CDR) cognitive test battery despite having undergone 2 training
研究者
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