A phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome (ABATE) - ACI-24-AD-DS-2102

AC Immune S.A.0 个研究点目标入组 190 人开始时间: 2022年5月10日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 190

研究概览入排标准研究者记录与标识符相似试验

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

•Part 1 : Age =50 and =85 years at screening., Part 2 : Age =35 and =50 years at screening (subjects with DS with age =35 and =39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and/or in biofluids)., Part 2 : Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21., Part 2 : PET scan at screening consistent with the presence of amyloid pathology., Part 2 : Subjects, their legal representatives (if applicable) and/or their study partners, in the opinion of the investigator, are able to understand the details of the study and to provide written informed consent before starting any study-related activities., Part 2 : In the opinion of the investigator, subjects, their legal representatives (if applicable), and/or their study partners or informants are able to fully participate in the study, are sufficiently proficient in the official languages(s) of the country they are living in, and are capable of reliably completing study assessments., Part 2 : Females who are either post-menopausal for at least 1 year and/or surgically sterilized, or females of childbearing potential or not post-menopausal must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of their participation. Male participants in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by female partners during the whole study duration., Part 2 : Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification., Part 2 : Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the subject and who is able to provide reliable answers to questions related to the subject, according to the study investigator., Part 1 : Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging-Alzheimer’s Association (NIA-AA) criteria., Part 1 : PET scan at screening consistent with the presence of amyloid pathology., Part 1 : Clinical Dementia Rating (CDR)-Global Score of 0.5., Part 1 : Subjects who in the opinion of the investigator are able to understand the details of the study and to provide written informed consent., Part 1 : Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and/or memantine for at least 2 months prior to baseline., Part 1 : Subjects cared for by a reliable spouse, informant, or study partner to assure compliance, assist with clinical assessments, and report safety issues, and spouse, informant or study partner consents to serve in this role., Part 1 : Females who are either post-menopausal for at least 1 year and/or surgically sterilized, or females of childbearing potential or not post-menopausal must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of their participation. Male participants in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by fema

排除标准

•Part 1 and Part 2 - Comorbidities: Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study vaccine (eg, moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator’s judgement., Part 1 and Part 2 - Comorbidities: History of inflammatory neurological disorders, Part 1 and Part 2 - Comorbidities: History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer which have been fully removed and are considered cured., Part 1 and Part 2 - Comorbidities: History of chronic or recurrent infections judged to be clinically significant by the investigator and which would potentially hamper the evaluation of efficacy and safety assessments., Part 1 and Part 2 - Comorbidities: History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the investigator., Part 1 and Part 2 - Comorbidities: History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and/or medications., Part 1 and Part 2 - Comorbidities: Clinically significant abnormal vital signs including sustained sitting blood pressure >160/90 mm Hg., Part 1 and Part 2 - Comorbidities: Significant risk of suicide, defined using the C-SSRS as the subject answering yes” to suicidal ideation questions 4 or 5 or answering yes” to suicidal behavior within the past 12 months., Part 1 and Part 2 - Comorbidities: Clinically significant infections or major surgical operation within 3 months prior to screening., Part 1 and Part 2 - Comorbidities: Planned surgery anticipated to occur during participation in the study must be reviewed and approved by the medical monitor at screening., Part 1 and Part 2 - Comorbidities: Subjects who have donated blood or blood products in the 30 days before screening or who plan to donate blood while participating in the study., Part 1 and Part 2 - Comorbidities: Subjects considered to be unable to be compliant with study-related activities (eg, completion of any study exams and assessments, respect of visit schedule and/or treatment administration) and/or to have comorbidities preventing the completion of any study exams and assessments (eg, significant hearing or visual impairments or other disabilities) according to the investigator., Part 1 and Part 2 - Comorbidities: Subjects with clinically uncontrolled diabetes mellitus and/or with hemoglobin A1c levels of =8.0 %., Part 1 and Part 2 - Comorbidities: DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years., Part 1 and Part 2 - Comorbidities: History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted., Part 1 and Part 2 - Comorbidities: Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening., Part 1 and Part 2 - Comorbidities: Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disea

研究者

发起方

AC Immune S.A.

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