EUCTR2016-003288-20-ES进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche LTD0 个研究点目标入组 750 人开始时间: 2017年1月19日最近更新:
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
- 750
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
- •- Aged between 50 and 85 years at screening, inclusive
- •- Weight between 40 and 120 kg, inclusive
- •- Availability of caregiver
- •- Fluency in the language used at the study site
- •- Willingness and ability to complete all aspects of the study (including magnetic resonance imaging [MRI], lumbar puncture [if applicable], clinical genotyping, and positron emission tomography (PET) imaging [if applicable]); the patient should be capable of completing assessments either alone or with the help of the caregiver
- •- Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- •- For men and women Use appropriate contraceptive measures or agreement to refrain from heterosexual intercourse for at least 8 weeks after last dose of drug study
- •- For men only: agreement to refrain from donating sperm during treatment for at least 8 weeks after last dose of drug study
- •- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) Aß1-42 levels as measured on the Elecsys ß-Amyloid(1-42) Test System OR amyloid PET scan by qualitative read by the core/central PET laboratory
- •- Demonstrated abnormal memory function at early screening (up to 4 weeks before screening begins) or at screening
- •- Evidence of retrospective decline confirmed by a diagnosis verification form
- •- Mild symptomatology, as defined by a screening MMSE score of = 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0. MMSE may be performed at early screening (up to 4 weeks before screening begins) or screening
- •- Meets National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia or prodromal Alzheimer’s disease
- •- If the patient is receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
- •- Inclusion is subject to review of clinical criteria at screening
- •- Patient must have completed at least 6 years of formal education after the age of 5 years
- •- For enrollment into the China Extension Phase, patients must have residence in the People’s Republic of China
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •- Any evidence of a condition other than AD that may affect cognition
- •- History of any condition that is clinically significant and may result in cognitive impairment including
- •Infections with neurological sequelae such as syphilis
- •Autoimmune disorders that cause progressive neurological disease associated with cognitive deficits
- •History of central nervous system trauma (e.g. cerebral contusion)
- •History of presence of intracranial tumour (e.g. glioma)
- •- History or presence of clinically evident vascular disease that could potentially affect the brain and that in the opinion of the investigator has the potential to affect cognitive function
- •- History or presence of any stroke with clinical symptoms within the past 2 years, or documented history within the last 6 months of an acute event consistent, in the opinion of the investigator, with a transient ischemic attack
- •- Presence on MRI of any cortical stroke regardless of age
- •- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- •- At risk of suicide in the opinion of the investigator
- •- Alcohol and/or substance abuse or dependence
- •- Inability to tolerate MRI procedures or contraindication to MRI
- •- MRI evidence of a) > 2 lacunar infarcts, b) any territorial infarct > 1 cm3, or c) any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least 1 confluent hyperintense lesion on the fluid-attenuated inversion recovery sequence, which is >= 20 mm in any dimension
- •- Evidence of more than 4 microbleeds and/or areas of leptomeningeal hemosiderosis (ARIA-H) as assessed by central review
- •- Presence of significant cerebral vascular pathology as assessed by MRI review
- •- Patients with cardiovascular disorders, hepatic/renal disorders, infections and immune disorders, metabolic/endocrine disorders as defined in protocol
- •- History of cancer unless considered cured or unlikely to require treatment within 5 years
- •- Screening folic acid or vitamin B12 levels that are sufficiently low that deficiency may be contributing to cognitive impairment
- •- Screening hemoglobin A1c (HbA1C) > 8% (retesting is permitted if slightly elevated) or poorly controlled insulin-dependent diabetes (including hypoglycemic episodes)
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Poor peripheral venous access
- •- Other causes of intellectual disability that may account for cognitive deficits observed at screening
- •- Sleep apnea that requires treatment or other significant respiratory diseases likely to result in cognitive impairment
- •- Clinically significantly abnormal blood or urine test results at screening and that remain abnormal at retest
- •- Impaired coagulation
- •- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- •- Any other severe or unstable medical condition that, could be expected to progress, recur, or change to such an extent that it could put the patient at special risk, bias the assessment of the clinical or mental status of the patient to a significant degree, interfere with the patient’s ability to complete the study assessments, or would require the equivalent of institutional or hospital care
- •- Residence in a skilled nursing facility such as a convalescent home or long-term care facility: Patients who subsequently require residence in these facilities during the study may continue in the
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