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.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 219
- 主要终点
- Cognitive Performance - ADAS-cog+
研究概览
简要总结
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease.
Study phase: II
Indication: Alzheimer´s Disease
Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
详细描述
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease.
Study phase: II
Indication: Alzheimer´s Disease
Study objectives: Primary:
To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (non-childbearing potential) with a diagnosis of Alzheimer's Disease according to the NINCDS-ADRDA clinical criteria.
- •Mild to moderate stage of Alzheimer's disease according to MMSE 18-26 inclusive.
- •Modified Hachinski Ischemic Scale equal to or below
- •Geriatric Depression Scale below or equal
- •If anticholinesterasic treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
- •If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
- •Exclusion criteria:
- •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.)
- •A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.
- •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 defined
- •antiepileptics
- •anticholinergics
- •nootropics (including Ginkgo)
- •centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine,)
- •opioid containing analgesics
- •anti-inflammatory agents, cortico-steroids or immunosuppressants
- •Cimetidin as gastroprotective drug
- •Severe thrombocytopenia defined as platelet counts <100.000 per mm
- •Coagulation disorders
排除标准
- 未提供
研究组 & 干预措施
Lornoxicam
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
干预措施: Lornoxicam (Drug)
Placebo
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive Performance - ADAS-cog+
时间窗: 6 months double blind, 6 months open-label (optional)
Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items). Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind).
次要结局
- Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI(6 months double-blind, 6 months open label (optional))