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临床试验/EUCTR2010-021218-50-BG
EUCTR2010-021218-50-BG进行中（未招募）1 期

A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease

AB Science0 个研究点目标入组 594 人开始时间: 2013年8月2日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
594
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

  • •Inclusion criteria
  • •1. Male or female patient
  • •2. Age = 50 years, weighing more than = 49,9 kg and with a Body Mass Index (BMI) >18 at screening
  • •3. Patient and/ or caregiver able to understand the patient card and to follow the patient card procedures in case
  • •of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of
  • •4. Menopause = 2 years for female patient
  • •5. Patient with dementia of Alzheimer's type, according to DSM-IV criteria
  • •6. Patient with probable Alzheimer' disease according to NINCDS-ADRDA criteria
  • •7. Patient with MMSE = 12 and = 25 at baseline
  • •8. Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil,
  • •rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at
  • •baseline, with no changes foreseen in therapy throughout the study
  • •9. Patient with adequate organ function at screening and baseline:
  • •· Absolute Neutrophils Count (ANC) = 2 x 109/L
  • •· Hemoglobin = 10 g/dL
  • •· Platelets (PTL) = 100 x 109/L
  • •· AST/ALT = 3 ULN
  • •· Bilirubin = 1.5 ULN
  • •· Albuminemia > 1 x LLN
  • •· Creatinine clearance > 50 mL/min
  • •· Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria = 1+ on the dipstick, 24 hours proteinuria
  • •must be < 1.5g/24 hours
  • •10. Patient with a regular and reliable caregiver. The designated caregiver must be sufficiently familiar with the
  • •patient (as determined by the investigator) to provide accurate data. The caregiver must have regular contact
  • •with the patient (i.e., an average of 10 or more hours per week), must be able to observe for possible adverse
  • •events, must be able to oversee patient’s compliance with the study treatment and to report on the patient’s
  • •status and must be able to accompany the patient to all visits
  • •11. Patient, identified caregiver and, if applicable, patient surrogate able and willing to comply with study visits
  • •and procedures per protocol, understand, sign, and date the informed consent form at screening visit prior to
  • •any protocol-specific procedures performed
  • •12. Male patient with a female partner of childbearing potential who agrees to use a highly effective method of
  • •contraception and an acceptable method of contraception by his female partner during the study and for 3
  • •months after the last treatment intake or who agrees to use an acceptable method of contraception and a
  • •highly effective method of contraception by his female partner during the study and for 3 months after the
  • •last treatment intake.
  • •? Highly effective methods of contraception include:
  • •- Combined (estrogen and progestogen containing) hormonal contraception associated with
  • •inhibition of ovulation: oral, intravaginal, or transdermal
  • •- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral,
  • •injectable, or implantable
  • •- Intrauterine device (IUD)
  • •- Intrauterine hormone-releasing system (IUS)
  • •- Bilateral tubal occlusion
  • •- Vasectomized male (azoospermia assessed medically)
  • •- Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical
  • •trial and the preferred and usual lifestyle of the patient)
  • •? Acceptable methods of contraception include:
  • •- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary
  • •mode of action
  • •- Male or female condom with or without spermicide
  • 另有 4 项未显示

排除标准

  • •Exclusion criteria
  • •1. Patient with any other cause of dementia not due to Alzheimer's disease, based on specific examination
  • •including a brain neuro-imagery exam within the last 6 months:
  • •· Other central nervous condition causing progressive deficits in memory and cognition, e.g.
  • •cerebrovascular disease (patient with not more than 4 microbleeds and not more than 2 lacunes at the
  • •MRI could be enrolled in the study), Parkinson's disease, Huntington's disease, brain tumor…
  • •· Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid
  • •deficiency, niacin deficiency, neurosyphilis, HIV infection…
  • •· Substance-induced dementia
  • •2. Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms
  • •of delusions and delirium will be allowed in the study)
  • •3. Patient treated with any registered or putative cognitive/memory enhancer or disease modifier other than
  • •donepezil, galantamine, rivastigmine or memantine. (Patient taking Ginkgo Biloba can be enrolled providing
  • •it has been taken at a stable dose for at least 6 months).
  • •4. Patient with evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant
  • •psychiatric disorder
  • •5. Patient with active current bacterial (including tuberculosis), viral (including hepatitis B and C, HIV, EBV,
  • •CMV, herpes zoster), fungal, mycobacterium, protozoan, or other infection
  • •6. Patient with history of infection requiring hospitalization within 2 weeks of screening
  • •7. Patient presenting with cardiac disorders defined by at least one of the following conditions:
  • •· Patient with recent cardiac history (within 6 months) of:
  • •- Acute coronary syndrome
  • •- Acute heart failure (class III or IV of the NYHA classification)
  • •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation,
  • •resuscitated sudden death)
  • •· Patient with cardiac failure class III or IV of the NYHA classification
  • •· Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
  • •block 2 and 3, sino-atrial block)
  • •· Syncope without known aetiology within 3 months
  • •· Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic
  • •hypertension
  • •8. Patient with chronic diarrhea
  • •9. Patient presenting with oedemas
  • •10. Patient with co existing dermatological disease (e.g. eczema, psoriasis) or history of skin allergy
  • •11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage
  • •consumption that would interfere with the ability to comply with the study protocol, or current or past
  • •psychiatric disease that might interfere with the ability to comply with the study protocol or give informed
  • •12. Patient with life expectancy < 1 year
  • •Previous medications:
  • •13. Patient treated with any investigational agent within 4 weeks of screening

研究者

发起方
AB Science

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