EUCTR2009-011098-34-AT进行中（未招募）不适用
A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the efficacy and safety of Lornoxicam in patients with mild to moderate probable Alzheimer’s Disease.
JSW Lifesciences GmbH0 个研究点目标入组 220 人开始时间: 2009年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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 50 - 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 criterion 3).
- •4. Mild to moderate stage of Alzheimer’s disease according to MMSE 18-26 inclusive.
- •5. Previous decline of cognition for more than 6 months.
- •6. Modified Hachinski Ischemic Scale equal to or below 4.
- •7. Geriatric Depression Scale below or equal 7.
- •8. Female patients must be either surgically sterilized or at least 1 year postmenopausal.
- •9. A caregiver is available and is living in the same household, or interacts regularly with the patient or patients living at home or old people’s home.
- •10. General health status acceptable for a participation in a 12 month clinical trial.
- •11. Ability to swallow tablets.
- •12. If anticholinesterasic treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
- •13. If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
- •14. Stable pharmacological treatment response of any other chronic condition for at least one month prior to screening.
- •15. No daily-regular/chronic intake of medications acting on central nervous system, immunosupresants, steroids or non-steroid anti-inflammatory agents except the following allowed treatments:
- •- SSRIs as antidepressants if they are administered at a stable and well tolerated dose for two months prior to baseline evaluation
- •- Drugs at a stable and well tolerated dose to symptomatic treatment of mild behavioural disorder, sleep onset-insomnia or mild depressive mood:
- •Zolpidem max 10 mg/day
- •Trazodon max 150 mg/day
- •Prothipendyl-Hydrochloridmonohydrat max 80 mg/day
- •Mirtazapin max 30 mg/day
- •- Acetylsalicylic acid max 100 mg/day.
- •16. Signed informed consent by caregiver and patient (or legal guardian if applicable) prior to the initiation of any study specific procedure.
- •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. Failure to perform screening examinations.
- •2. Change of chronic concomitant medication during screening period.
- •3. 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 confirmed by current analyses not older than 1 month, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
- •4. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.
- •5. 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:
- •- chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, Alkaline Phosphatase > 2.5 ULN)
- •- respiratory insufficiency
- •- renal insufficiency (serum creatinine > 2 mg/dl or creatinine clearance = 45 ml/min according to Cockgroft-Gault formula).
- •- gastro-intenstinal bleeding, cerebrovascular bleeding or other conditions with bleeding disorders
- •- active peptic or duodenal ulceration or with a history of recurrent peptic or duodenal ulceration
- •- hypersensitive reactions (asthma, rhinitis, angioedema or urticaria) to NSAIDs including Lornoxicam
- •- heart disease (atrial fibrillation, myocardial infarction, unstable angina, history or clinical evidence of heart failure, cardiomyopathy within 6 months before screening)
- •- bradycardia (heart rate < 50/min.) or tachycardia (heart rate > 95/min.)
- •- uncontrolled hypertension (defined as a repeatedly elevated blood pressure exceeding 140 over 90 mmHg - a systolic pressure above 140 with a diastolic pressure above 90)
- •- 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, defined by HbA1c > 8.5
- •- malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer
- •- metastases
- •6. Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
- •7. Women who are fertile and of child bearing potential.
- •8. Chronic daily drug intake for a time period of = 14 days or expected for = 14 days:
- •- antidepressants, benzodiazepines, neuroleptics, major sedatives or other anti-inflammatory drugs including acetylic salicylic acid (except those defined as allowed in the inclusion criterion number 15)
- •- antiepileptics
- •- anticholinergics
- •- nootropics (including Ginkgo)
- •- centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine)
- •- opioid containing anal
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