CTIS2024-510888-39-00招募中1 期
AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel Treatment Arm, 216 Week Study with an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial) - BAN2401-G000-303
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,400
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
- •Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, CSF, or plasma testing. a. Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity <65 years, before Screening: i. First degree relative diagnosed with dementia onset before age 75, or ii. Known to possess at least 1 APOE4 allele, or iii. Known before Screening to have elevated brain amyloid according to previous plasma biomarker results, PET imaging, or CSF testing., Global CDR score of 0 at Screening, Mini Mental State Examination (MMSE) score =27 (with educational adjustments) at Screening. Educational adjustment requirements are: a. If =12 years of education, MMSE required to be =25 b. If 13 to 15 years (inclusive) of education, MMSE required to be =26 c. If =16 years of education, MMSE required to be =27, Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at Screening of =6, A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately >40 centiloids on Screening scan. A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 centiloids on screening scan., Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject’s daily function., Provide written (or electronic, if allowed per country-specific regulations) informed consent, Willing and able to comply with all aspects of the protocol, Extension Phase 1.Completed the Core Study, or meet the following progression criteria during the Core Study: • Two (2) consecutive CDR visits with Global Scores > zero when measured at least 6 months apart within the Core Study • The Principal investigator's confirmation that the participant has clinically declined consistent progression to EAD 2. Must continue to have a study partner who is willing and able to provide follow-up information on the subject throughout the course of the Extension Phase. The study partner must provide separate written informed consent for the Extension Phase. Study partners must continue to have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily functions. 3. Provide written informed consent for the Extension Phase. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required and in accordance with local laws, regulations, and customs, plus the written informed consent of a legal representative (capacity to consent and the definition of a 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, Spain), they will not be enrolled. 4. Willing and able to comply with all aspects of the protocol.
排除标准
- •Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). For women of childbearing potential, a separate baseline assessment is required if a negative Screening pregnancy test was obtained more than 72 hours before the first dose of study drug., Known to be human immunodeficiency virus (HIV) positive, Any other clinically significant abnormalities that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety., Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male subjects with treatment cycles completed at least 6 months before Screening). Subjects who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded., 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 Baseline, 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, opioids, or THC in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse, Taking prohibited medications., Participation in a clinical study involving those compounds defined in the protocol., Planned surgery during the Prerandomization Phase or within 3 months of Randomization, which requires general anesthesia, Extension Phase 1. Discontinued from the Core Study or from study treatment. 2. Under study drug interruption due to ARIA or other AE at the time of transition to the Extension Phase., Females of childbearing potential who: ? Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: o total abstinence (if it is their preferred and usual lifestyle) o an intrauterine device or intrauterine hormone-releasing system o a contraceptive implant o an oral contraceptive (with additional barrier method) (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation.) o have a vasectomized partner with confirmed azoospermia ? Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. (revised per Amendment 03) NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age range, and without other known or suspected cause) or have been
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