EUCTR2017-001673-17-FI进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia
Integrative Research Laboratories AB0 个研究点目标入组 40 人开始时间: 2017年8月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •1. Male or female 55-85 years of age.
- •2. Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and estradiaol <200 pmol/L is confirmatory]).
- •3. Fertile male patients must be willing to use condom and refrain from donating sperm during the study and ensure that their fertile female partners are using contraceptive methods to prevent pregnancy .
- •4. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria.
- •5. Diagnosis of PDD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) criteria, with onset of symptoms of dementia at least two years following the first diagnosis of idiopathic PD.
- •6. Mini Mental State Examination (MMSE) score of =12 and = 26 at screening.
- •7. On a stable regimen of anti-Parkinson's medications for at least 30 days prior to screening (Selegelin not allowed), and willing to continue the same doses and regimens during study participation.
- •8. Availability of a responsible caregiver at least four days per week.
- •9. Able to cooperate and participate in study related procedures.
- •10. Written informed consent for participation in the study given by the patient.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1. An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations.
- •2. A score of 5 (wheelchair bound or bedridden) in the on-state on the Modified Hoehn and Yahr Staging (UPDRS Part 5).
- •3. A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD.
- •4. A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
- •5. A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
- •6. A current diagnosis of a major depressive episode according to DSM-IV criteria.
- •7. A history of stereotaxic brain surgery for PD.
- •8. Any history of a clinically relevant heart condition, including prolonged QTc (>450 ms), clinically relevant cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
- •9. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; symptomatic orthostatic hypotension; hepatic disease; renal failure, history of abnormal renal function; or seizures.
- •10. Creatinine clearance <45 ml/min (calculated according to the Cockcroft-Gault formula).
- •11. History of severe allergy/hypersensitivity or severe on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL752.
- •12. Treatment with Warfarin within three (3) months before study treatment.
- •13. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study.
- •14. Current or history of alcohol abuse and/or use of drugs of abuse.
- •15. Any planned major surgery within the duration of the study.
- •16. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement.
研究者
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