EUCTR2020-005755-20-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer's Disease and APOE4/4 Genotype - APOLLOE4
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •1. Male or female between the ages of 50 and 80 years (inclusive).
- •2. Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the NIA-AA Working Group Criteria
- •3. Homozygous for the e4 allele of the APOE gene (APOE4/4).
- •4. MMSE score at Screening of 22 to 30 (inclusive).
- •5. CDR Global score at Screening of 0.5 or 1, and a CDR Memory Box score = 0.5.
- •6. RBANS delayed memory index score = 85.
- •7. Evidence of progressive memory loss over the last 12 months per investigator assessment as captured on the diagnostic verification form.
- •8. Can complete the cognitive testing and all other required study procedures.
- •9. Has completed at least 6 years of formal education after age of 5 years, and is able to read at minimum of 6th grade level or equivalent per investigator assessment.
- •10. Lives at home independently, in a senior living facility, or in an assisted living facility.
- •11. Body weight between 48-120 kg (inclusive), and body mass index (BMI) between 17-35 (inclusive).
- •12. Except for a diagnosis of AD and the presence of stable medical conditions, is, in the opinion of the Investigator, in good general medical health based upon the results of medical history, physical examination, laboratory tests, vital signs, and ECG.
- •13. Has a reliable caregiver or study partner who is willing and able to sign an ICF, to accompany the subject to study visits, and adhere to study requirements. Caregiver or study partner must be able to provide accurate information on subject’s cognitive and functional ability and have face to face contact with subject of at least 10 hours per week.
- •See protocol for further inclusion criteria
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 210
排除标准
- •1. Screening brain MRI indicative of significant abnormality per central reader, other than AD related atrophy, including, but not limited to; prior hemorrhage > 1 cm3, prior large vascular territorial infarct, > 2 lacunar infarcts (size > 1.5 cm) outside the brain stem, severe white matter changes (deep white matter changes Fazekas grade = 3), superficial hemosiderosis > 1 cm, ventriculomegaly related to normal pressure hydrocephalus, or aneurysm, vascular malformation, subdural hematoma, space-occupying lesion (e.g., meningiomas = 1 cm, abscess or brain tumor).
- •2. Diagnosis of neurodegenerative disorder other than AD.
- •3. Diagnosed with MDD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5), within one year prior to screening. A subject who does not meet current criteria for MDD and who is on stable doses of antidepressants or mood stabilizers may be included in the study at the discretion of the Investigator.
- •4. Currently taking memantine or has taken memantine within 12 weeks prior to the Screening – Part 2 Visit.
- •5. History of suicidal behavior within one year prior to screening; or has ongoing suicidal ideation with intent, with or without a specific plan or method (e.g., positive response to C-SSRS items 4 or 5 during the past 6 months).
- •6. History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 10 years).
- •7. Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.
- •8. Medically confirmed history of recent myocardial infarction or unstable, untreated coronary artery disease, or angina pectoris (within 1 year prior to the Screening – Part 2 Visit).
- •9. Lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder.
- •10. History of, or currently has, any clinically significant ECG finding, or a QT interval corrected by Fridericia’s method (QTcF) of > 450 msec for males and > 470 msec for females.
- •11. History of cancer, diagnosed and treated within the last 3 years prior to the Screening – Part 2 Visit, with the exception of the following: (a) treated basal cell carcinoma of the skin, (b) treated cutaneous squamous cell carcinoma in situ, (c) treated in situ or Stage 1 prostate cancer, and (d) treated in situ cervical cancer (all require approval by the Sponsor’s Medical Officer).
- •12. Has donated blood > 250 mL within 6 weeks prior to the Screening – Part 2 Visit.
- •13. History of alcohol or drug dependence or abuse within 2 years prior to the Screening – Part 2 Visit or tests positive for drugs of abuse [i.e., amphetamines, MDMA, barbiturates, benzodiazepines, cannabinoids, cocaine, phencyclidine, ethanol, and opiates] at the Screening – Part 2 Visit.
- •14. Any significant medical condition or infection (e.g., uncontrolled cardiovascular, GI, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or malignancy) that is unstable and that would either: (a) place the subject at undue risk from administration of study drug or from undergoing study procedures, or (b) interfere with the interpretation of safety or efficacy evaluations obtained in the course of the study.
- •15. Unable to swallow ALZ-801 tablets or has a known intolerance or hypersensitivity to tramiprosate or any of the excipients contained in the ALZ-801 tablets.
- •16. Hemoglobin level < 11 g/dL in male subjects or < 10 g/d
研究者
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