2024-513458-31-00已完成4 期
The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer’s Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- The primary and secondary endpoints measures will be collected through the DIAN Obs protocol. The primary endpoint for the interim analysis is the change from ART baseline to year 1 or year 2 in amyloid Pittsburgh compound B (PiB) PET standardized uptake value ratio (SUVR). The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating – Sum of Boxes (CDR-SB).
研究概览
简要总结
To determine the effects of amyloid removal on age of onset and clinical progression compared to external controls.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Previously participated in the DIAN-TU-001 gantenerumab OLE period.
- •Willing to participate in ongoing anti-amyloid therapy with informed consent by participant or legally authorized representative.
- •People of childbearing potential (POCBP), if partner is not sterilized, must agree to use highly effective contraceptive measures methods that can achieve a failure rate of less than 1% per year when used consistently and correctly from Consent (V1) until eight (8) weeks after last dose of any study drug. Such methods include: a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable c. intrauterine device (IUD) d. intrauterine hormone-releasing system (IUS) e. bilateral tubal occlusion f. vasectomized partner g. sexual abstinence
- •Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and is willing to complete DIAN Obs procedures and assessments.
- •Able to undergo safety MRI scans as required.
- •Vascular access adequate for study drug administration and safety monitoring.
- •Body Mass Index (BMI) greater than 17 and less than 35 at Visit 2 (Entry Visit).
- •Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, spend sufficient time with the subject on a regular basis such that the study partner can reliably fulfil the study requirements. A permanent study partner need not be living in the same residence with the subject. For such a study partner not residing with the subject, the investigator has to be satisfied that the subject can contact the study partner readily during the times when the study partner is not with the subject.
排除标准
- •Has any significantly increased risks associated with amyloid-related imaging abnormalities characterized by edema/effusion (ARIA-E), ARIA characterized by microhemorrhage (ARIA-H MCH) or superficial siderosis (ARIA-H SS) and vascular factors reviewed by the medical monitoring team (see Section 7.4.1). Risks to be reviewed include: a. History of recurrent ARIA-E (2 or more episodes regardless of location). b. More than 4 ARIA-H MCH. c. History of ARIA-H SS. d. More than 2 lacunar infarcts or stroke involving a major vascular territory.
- •Uncontrolled medical condition that is life threatening or precludes interpretation of AD.
- •Uncontrolled blood pressure including mean arterial pressure exceeding 97 mm Hg.
- •Uncontrolled seizure disorder.
- •Presence of certain implanted medical devices, such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body which would preclude MRI scan.
- •Answer “yes” to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months of Visit 2 (Entry Visit), or has been hospitalized or treated for suicidal behavior in the past 5 years before Entry.
- •Ongoing auto-immune condition, bleeding diathesis, or neutropenia (platelets lower than 50,000) major depression or psychiatric condition.
- •Exposure to other AD investigational agents within the past six months, or five half-lives from Visit 2 (Entry Visit) whichever is longer.
- •Active cancer/malignancy that could interfere with study evaluations.
- •Requiring full anticoagulation or on high dose or dual antiplatelet therapy (daily aspirin 325 mg or less allowed).
- •History of macrohemorrhages >1 cm.
- •Hypersensitivity to lecanemab or any of the excipient, or to any monoclonal antibody treatment.
- •Breastfeeding.
结局指标
主要结局
The primary and secondary endpoints measures will be collected through the DIAN Obs protocol. The primary endpoint for the interim analysis is the change from ART baseline to year 1 or year 2 in amyloid Pittsburgh compound B (PiB) PET standardized uptake value ratio (SUVR). The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating – Sum of Boxes (CDR-SB).
The primary and secondary endpoints measures will be collected through the DIAN Obs protocol. The primary endpoint for the interim analysis is the change from ART baseline to year 1 or year 2 in amyloid Pittsburgh compound B (PiB) PET standardized uptake value ratio (SUVR). The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating – Sum of Boxes (CDR-SB).
次要结局
- The secondary endpoint analysis will be the change from ART baseline to year 5 in the following assessments: imaging (amyloid PET, tau PET), clinical (Functional Assessment Scale), plasma and CSF biomarkers of disease progression including Aβ42/40, tau species (%phosphorylated tau217, 205, 231), total tau, and microtubule-binding region (MTBR) species, e.g. MTBR-243. These assessments are collected at the initial DIAN Obs Visit (which coincides with DIAN‐TU‐003 V2) and...Truncated due to limit
研究者
Susan Mills, Sr. Director, Clin O
Scientific
Washington University School Of Medicine
研究点 (1)
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