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6月17日最近更新: 2013年3月4日

适应症

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

研究概览入排标准研究者记录与标识符相似试验

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, which will be assessed at screening (visit 0) and baseline (visit 1). Patients with ineligibel score have to be withdrawn at screening or at baseline.
•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.)
•- major infarct(defined as regional infarct in the territory of a.cerebri media or a.cerebri anterior or a. cerebri posterior) 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 with exception of one unique attack in the patient's medical history
•- 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)
•- symptoms like tachypnoe, ortopnoe, central cyanosis or retraction accompanied with the decreased O2 saturation (pO2 less than 8kPa
•- serum creatinine > 2 mg/dl or creatinine clearance = 45 ml/min. In case of creatinin clearance = 45ml/min., an alternative verification of the renal function has to be done by the analysis of Cystatin C. In case of normal level of Cystatin C the patient can be included.
•- 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 > 100/min.)
•- uncontrolled hypertension - a systolic pressure above 145 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 sedati

研究者

发起方

JSW Lifesciences GmbH

相似试验

进行中（未招募）

不适用

EUCTR2009-011098-34-ATJSW Lifesciences GmbH220

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. - CR081101/CO14950Alzheimer's disease

EUCTR2009-011098-34-CZJSW Lifesciences GmbH220

进行中（未招募）

不适用

EUCTR2009-011098-34-SKJSW Lifesciences GmbH220

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.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseAlzheimer's disease

EUCTR2008-003659-63-ATBTG International Ltd240

进行中（未招募）

1 期

A multicenter (several study centers) double-blind (neither the physician nor the patient knows if the FGTW or the placebo is given), placebo controlled (a comparator without an active substance), randomized (random distribution) pilot trial to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (administration of Fibrinogen – a substance to stop or reduce the bleeding - immediately at the accident location) in trauma patients, presumed to bleed (FI in TIC)

EUCTR2010-022923-31-ATMedizinische Universität Innsbruck / Univ.-Klinik für Allgem. u. Chirurg. Intensivmedizin60