CTIS2024-510887-22-00进行中（未招募）1 期
A Placebo-Controlled, Double-Blind, Parallel-Group, 18 Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease - BAN2401-G000-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,906
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
- •Diagnosis; MCI due to AD–intermediate likelihood: Meet NIA-AA core clinical criteria for MCI due to AD–intermediate likelihood., Diagnosis; Key Inclusion Criteria that must be met by all subjects: BMI >17 and <35 at Screening., Diagnosis; Key Inclusion Criteria that must be met by all subjects: If receiving an approved AD treatment, such as AChEIs, or memantine, or both for AD, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-naïve subjects for AD can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other (ie, non-AD-related) permitted concomitant medications for at least 4 weeks prior to Baseline. Use of memantine will not be allowed for Japanese subjects., Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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 fulfill 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. If in doubt about whether a subject's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Study partners need to participate in person for visits where clinical assessment of CDR (global and CDR-SB), EQ-5D-5L, QOL-AD, ADCS MCIADL and Zarit Burden Interview take place., Diagnosis; Key Inclusion Criteria that must be met by all subjects: Provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit subjects who lack capacity to consent to participate in this study (eg Germany and Spain), they will not be enrolled., Diagnosis; Key Inclusion Criteria that must be met by all subjects: Willing and able to comply with all aspects of the protocol., Extension: See protocol for full details., Diagnosis; MCI due to AD–intermediate likelihood: A global CDR score of 0.5 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline., Diagnosis; MCI due to AD–intermediate likelihood: Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; must be corroborated by an informant., Diagnosis; Mild AD dementia: Meet NIA-AA core clinical criteria for probable AD dementia., Diagnosis; Mild AD dementia: A global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline., Diagnosis; Key Inclusion Criteria that mus
排除标准
- •Females who are breastfeeding or pregnant at screening or Baseline., Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment., Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study., Subjects with a bleeding disorder that is not under adequate control (including a platelet count <50,000 or INR >1.5 for subjects who are not on anticoagulant treatment. Subjects who are on anticoagulant therapy should have their anticoagulant status optimized and be on a stable dose for 4 weeks before Screening. Subjects who are on anticoagulant therapy are not permitted to participate in CSF assessments., Have TSH above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all subjects whether or not they are taking thyroid supplements., Abnormally low serum vitamin B12 levels for the testing laboratory., Known to be HIV positive., Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline which in the opinion of the investigator require further investigation., Subjects with malignant neoplasms within 3 years of Screening., Answer yes to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening., Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Subjects who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if in the clinical opinion of the investigator, this is due to the subject taking prior/concomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse., Females of childbearing potential who: a. Within 28 days before study entry, did not use a highly effective method of contraception b. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation., Any other medical conditions which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments., Subjects who are taking prohibited medications., Participation in a clinical study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before Screening, unless it can be documented that the subject was randomized to placebo., Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapies and any BACE inhibitor therapies) unless it can be documented that the subject only received placebo., Subjects who have any known prior exposure to BAN2401., Subjects who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to Screening unless it can be documented that the subject was in a placebo treatment arm., Participated in any other investigational medic
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