CTIS2023-509807-34-00进行中（未招募）1 期
A Phase 2/3 Double-Blind, Randomized, Placebo-Controlled Adaptive Design Trial to Evaluate the Efficacy and Safety of Intravenous ACU193 in Early Alzheimer’s Disease - ACU193-201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,885
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Age 50 to 90 years (inclusive) at the time of signing the Informed Consent Form (ICF)., 10. Have a reliable informant or study partner who is willing and able to perform the roles specified in the study partner ICF, including providing support and accompanying the participant to study visits or be available by telephone at designated times., 11. Individuals with prior childbearing potential who are: a. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or b. Post-menopausal – defined as 12 months with no menses without an alternative medical cause., 12. Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)., 13. Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study., 14. Suicide risk, as determined by meeting any of the following criteria: a.Any suicide attempt or preparatory acts/behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening in the last six months. b.Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening. c.Significant risk of suicide, as judged by the site investigator., 15. Alcohol use disorder and/or substance use disorder within the last five years., 16. Conditions that may affect cognitive assessments during the study (e.g., planned surgery requiring general anesthesia)., 17. Known genetic mutation that causes autosomal dominant AD., 2. Sperm-producing individuals in a sexual relationship with individuals of childbearing potential must use adequate contraception (e.g., condom) and must not donate sperm during the study and for 180 days after the last dose of the study drug., 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures., 4. Able to give written informed consent., 5. Body weight of at least 30 kg (66 lbs) and no more than 160 kg (352 lbs) at Screening, 6. Consent to APOE4 genotype status assessment., 7. Meet all the following criteria: a. NIA-AA criteria for MCI due to AD or probable AD. b. Screening and Baseline score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE). c. Screening and Baseline score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening and Baseline score =0.5 on the CDR Memory Box score. d. Evidence of cerebral amyloid accumulation by either PET scan or CSF. (CSF should not be collected from participants on anticoagulation treatment.) Participants will have only one assessment to determine evidence of cerebral amyloid accumulation – CSF or amyloid PET. An amyloid screening blood test may be used prior to the amyloid PET or CSF test as an attempt to reduce the rate of negative amyloid PET scans, subject to availability., 8. If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses m
排除标准
- •1. Contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker and/or defibrillator that is not compatible with MRI., 10. Ongoing or new clinically significant laboratory abnormality, as determined by the site investigator., 11. Within one year before Screening, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (e.g., significant valvular disease, hypertrophic cardiomyopathy), hospitalization for arrhythmia, uncontrolled hypertension or clinically significant abnormalities in ECG, or history or presence of clinically significant QTc interval prolongation or family history of long QTc., 2. MRI of brain that is inconsistent with MCI or AD or results showing greater than four amyloid-related imaging abnormalities hemorrhage/hemosiderin deposition (ARIA-H), presence of any amyloid-related imaging abnormalities edema/effusions (ARIA-E), or superficial siderosis., 3. History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease, or any other neurological condition that may be contributing to cognitive impairment beyond that caused by the participant’s AD in the judgement of the investigator., 4. Received any investigational product within six months (24 weeks) prior to Baseline (Week 0)., 5. Received any monoclonal antibody within six months (24 weeks) prior to Baseline (Week 0) that reduces amyloid plaques or tau load in the brain, including ACU193., 6. Known allergy to biological products., 7. Immunologic disease requiring treatment with plasmapheresis. If a participant is on immunosuppressive drugs, the investigator should discuss the case with the medical monitor., 8. Modified Hachinski Ischemic Scale score >4., 9. Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study, including psychiatric, hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinological, immunologic, or hematologic disorders
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