EUCTR2010-021926-37-DE进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTER PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MABT5102A IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •Ability to provide written informed consent by the patient and a legally authorized health care representative for the patient
- •Ability and willingness of patient and a legally authorized health care representative to comply with the protocol’s requirements
- •Age 50-80 years
- •Body weight = 45 kg and = 120 kg
- •Adequate visual and auditory acuity in the investigator's judgment to allow for neuropsychological testing
- •Fluent in the language of the test assessments
- •Negative urine test for drugs of abuse (including medical marijuana) at screening
- •For female patients, a negative serum ß–human chorionic gonadotropin (ß-hCG) pregnancy test at screening
- •Normal thyroid-stimulating hormone (TSH) and vitamin B12 levels at screening
- •For male patients with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study
- •Availability of a person who can provide information on activities of daily living and behavior to complete the related assessments
- •This person must live with the patient at least 4 days per week and be familiar with the overall function and behavior of the patient.
- •Related to Neurology/Cognition
- •Diagnosis of probable AD according to the NINCDS-ADRDA criteria (McKhann et al. 1984)
- •MMSE score of 18-26 points at screening (Folstein et al. 1975)
- •GDS-15 score of < 6
- •CDR score of = 0.5
- •Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
- •Related to Medication
- •For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to screening, at a stable dose for at least the last 2 months prior to screening
- •For patients currently receiving other prescription medications: Treatment at a stable dose for = 1 month prior to screening
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Female patient with reproductive potential
- •Female patients must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months.
- •Severe or unstable medical condition that, in the investigator's or Sponsor's opinion, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
- •Related to Medical History/Conditions
- •History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
- •Presence of more than two micro- or macrohemorrhages as assessed by T2* weighted GRE MRI
- •History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
- •History or presence of intracranial tumor (e.g., meningioma, glioma)
- •Presence of potential metabolic cause of dementia or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities)
- •History or presence of infections that affect the brain (e.g., syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis, HIV encephalopathy)
- •History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., multiple sclerosis, lupus erythematosus, anti-phospholipid antibody syndrome, Behçet disease)
- •History or presence of psychiatric disease other than AD that may affect cognition, including but not limited to clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (e.g. major depression, schizophrenia, bipolar disorder)
- •History or presence of a neurologic disease other than AD that may affect cognition, including but not limited to Parkinson’s disease, corticobasal degeneration, dementia with Lewy bodies, Creutzfeldt–Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington’s disease, normal pressure hydrocephalus, and hypoxia
- •Presence of visual hallucinations, parkinsonism, chorea, eye movement abnormalities, dystonia, or gait disturbance suggestive of a non-AD diagnosis
- •History of seizures with the exception of childhood febrile seizures
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- •Known or suspected history of alcohol or drug abuse within the previous 5 years (DSM-IV criteria) Medical marijuana is allowed if stopped 3 months prior to screening.
- •Evidence of malignancies, acute infections, renal failure that requires dialysis, or other unstable medical disease
- •Hospitalization within 4 weeks prior to screening
- •History of atrial fibrillation
- •Thyroid disease unless euthyroid on treatment
- •Clinically significant laboratory or ECG abnormalities in the investigator’s judgement
- •Prolonged QTc interval (> 450 msec in males, > 470 msec in females)
- •Impaired renal function (creatinine > 2 times the upper limit of normal [ULN])
- •Impaired hepatic function (as indicated by transaminases > 1.2 x ULN or abnormalities in synthetic function tests judged by the investigator to be clinically significant)
- •Impaired coagulation (PT or PTT > 1.5 x ULN)
- •Platelet count < 100,000/uL
研究者
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