EUCTR2010-020109-34-IT进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Inclusion Criteria 1. Male/female outpatients (45- 80 years inclusive) 2. Idiopathic Parkinson’s disease (PD) (UK PDS Brain Bank Criteria) and Hoehn and Yahr Staging I-III at Screening. Diagnosis will be based on medical history and neurological examination 3. Subjects and informants must report cognitive impairment in at least one cognitive domain on the PDCognitive Questionnaire 4. Cognitive impairment must be confirmed by a total score = 26 on the Montreal Cognitive Assessment 5. Subjects must be able to speak, read, and write in the language in which the tests are written and must be able to perform all assessments in this language 6. Subjects treated with dopaminergic therapy at a stable dose for at least four weeks prior to Screening and for the duration of the study 7. Subjects must understand and sign the appropriate approved Informed Consent Form(s), one for the study (mandatory), one for the pharmacogenetic evaluation (optional)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria 1. Any indication of forms of Parkinsonism other than idiopathic PD 2. Parkinson’s disease Dementia 3. Dementia with Lewy Bodies 4. Any clinically significant DSM-IV-TR Axis I Disorders, current diagnosis of substance abuse, history of alcohol/drug abuse for three months prior to Screening 5. Mental/physical/social condition which could preclude performing efficacy or safety assessments 6. Severe white matter disease, multiple lacunar infarcts, signs of significant vascular changes on Magnetic Resonance Imaging 7. Signs/symptoms suggestive of transmissible spongiform encephalopathy or family members who suffer(ed) from such 8. Current history of severe dizziness/fainting on standing 9. Any cardiovascular disease or condition 10. Subjects with human immunodeficiency virus infection, positive results on hepatitis B/C antibody tests or on tests for hepatitis B surface antigen (unless vaccinated) 11. Neoplastic disease currently active/in remission for less than one year 12. Clinically significant/unstable medical conditions 13. End-of-dose wearing-off, on-off phenomena, disabling peak dose- or biphasic dyskinesia, unpredictable/ widely swinging fluctuations 14. Current or past participation in another trial within 30 days prior to Screening or treatment with any investigational product within 30 days or five half-lives, whichever was longer, prior to Screening 15. Clinically significant hypertension, contraindications/hypersensitivity to monoamine oxidase-Type B inhibitors 16. Anticholinergic medication and/or amantadine within four weeks prior to Screening 17. Opioids or MAO inhibitors within eight weeks prior to Screening (dextromethorphan allowed for cough). One tricyclic- or tetracyclic antidepressant or trazodone permitted if at low dose as sleeping aid 18. Acetylcholinesterase inhibitors/memantine within four weeks before initiation of study treatment or during the study 19. Depot neuroleptic drugs during the study or within one injection cycle, oral neuroleptics within four weeks prior to Screening (stable dose of quetiapine < 100 mg/day for eight weeks prior to Screening allowed) 20. Drugs with hepatotoxic potential within four weeks prior to Screening, radiation therapy, drugs with cytotoxic potential within one year prior to Screening 21. Subjects likely to be non-compliant/uncooperative 22. Women who are pregnant, lactating, attempting to conceive 23. Women of childbearing potential not willing to use adequate contraceptive method (unless surgically sterilized) for four weeks prior to, during, and four weeks after last dose of trial medication 24. Significant ophthalmologic abnormality 25. Limited/absent legal capacity
研究者
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