EUCTR2008-003659-63-AT进行中（未招募）不适用
A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of BGC20-1259 in patients with mild to moderate probable Alzheimer’s Disease. - BGC20-1259 Study in Alzheimer’s patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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. Men and women (non-childbearing potential) with a diagnosis of Alzheimer’s disease according to the NINCDS-ADRDA clinical criteria.
- •2. Age 60 - 85 years inclusive.
- •3. MRI or CT assessment within 12 months before baseline corroborating the clinical diagnosis and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3).
- •4. Mild to moderate stage of Alzheimer’s disease according to MMSE 15-26 inclusive.
- •5. Geriatric Depression Scale below or equal 7.
- •6. caregiver is available and is living in the same household, or interacts with the patient at least 4 times a week.
- •7. Patients living at home or old people’s home without continuous nursing care.
- •8. If anticholinesterase treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
- •9. If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
- •10. If SSRI or MAOI treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
- •11. No regular intake of medications acting on central nervous system or any anti-inflammatory agents.
- •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
- •1. Hospitalization or change of chronic concomitant medication 1 month prior to screening or during screening period.
- •2. Clinical, laboratory or neuroimaging findings consistent with:
- •other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Jacob-Creutzfeld Disease, Down’s syndrome, etc)
- •other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.)
- •cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
- •other central nervous system diseases (severe head trauma, tumors, subdural haematoma or other space occupying processes, etc.)
- •seizure disorder
- •other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
- •3. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.
- •4. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:
- •hepatic or respiratory insufficiency
- •renal insufficiency (serum creatinine >2mg/dl)
- •heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening)
- •bradycardia (heart beat <50/min.) or tachycardia (heart beat >95/min.)
- •hypertension or hypotension requiring treatment with more than 3 drugs
- •AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 and females >470 msec)
- •uncontrolled diabetes
- •malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer
- •metastases
- •5. Women who are fertile and of child bearing potential.
- •6. Chronic daily drug intake of:
- •antidepressants, benzodiazepines, neuroleptics or major sedatives
- •antiepileptics
- •anticholinergics
- •nootropics (including Gingko)
- •centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine, …)
- •opioid containing analgesics
- •non steroid anti-inflammatory agents, cortico-steroids or immunosuppressants
- •7. Suspected or known allergy to any components of the study treatments. Known allergies, including allergy to the study drug or its constituents or known cholinomimetic hyperreactivity
- •8. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
研究者
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