EUCTR2010-022598-32-ES进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP,MULTICENTER, PHASE II STUDY TO EVALUATETHE IMPACT OF MABT5102A ON BRAINAMYLOID LOAD AND RELATED BIOMARKERSIN PATIENTS WITH MILD TO MODERATEALZHEIMER?S DISEASE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •? Ability and willingness of patient 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
- •? For female patients, a negative serum ??human chorionic gonadotropin
- •(?-hCG) pregnancy test at screening
- •? Normal thyroid-stimulating hormone (TSH) level and vitamin B12 level
- •of ? 200 pg/mL 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 (caregiver) who can provide information on activities of
- •daily living and behavior in order to complete the study-specific assessments
- •This caregiver must have sufficient cognitive capacity, in the judgment of
- •the investigator, to accurately report upon the patient's function and
- •behavior. In addition, the caregiver must spend sufficient time with the
- •patient to be familiar with the overall function and behavior of the patient.
- •As guidance, a caregiver would ordinarily need to spend an average of at
- •least 8 hours per week with the patient in order for the caregiver to meet
- •the requirements for this study.
- •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)
- •? ADAS-Cog Delayed Word Recall score of ? 5 (i.e., ? 5 errors)
- •? 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 randomization, at a stable dose for at least the
- •last 2 months prior to randomization
- •? For patients currently receiving other prescription medications that might
- •affect cognitive function (e.g., antidepressants, antipsychotics): Treatment at
- •a stable dose for ? 1 month prior to randomization
- •Related to Brain Amyloid Load
- •? Brain amyloid load in the range expected for AD patients as assessed by an
- •expert, blinded visual reading of the screening florbetapir-PET scan
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •? Lack of peripheral venous access
- •? Inability to tolerate MRI or lumbar puncture procedures or contraindication to
- •MRI, including but not limited to pacemakers; implantable cardioverter
- •defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion
- •pumps; implanted nerve stimulators; metallic splinters in the eye;
- •other magnetic, electronic, or mechanical implants; or any other clinical
- •history or examination finding that, in the judgment of the investigator,
- •would pose a potential hazard in combination with MRI
- •? 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 opinion of the investigator or
- •Sponsor, would interfere with the patient's ability to complete the study
- •assessments or would require the equivalent of institutional or hospital care
- •Related to PET Imaging
- •? Inability to tolerate PET procedure
- •? Abnormal findings that, in the opinion of the investigator, may affect his or
- •her response to the radiopharmaceutical and related testing procedures
- •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)
- •? 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 infections that affect the brain function or history of infections
- •that resulted in neurologic sequelae (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)
- •A history of major depression is acceptable if no episode has been
- •reported within the previous 5 years.
- •? 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
- •? 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
- •? Positive urine test for drugs of abuse at screening or known or suspected
- •history of alcohol or drug abuse within the previous 5 years (DSM-IV criteria)
- 另有 4 项未显示
研究者
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