CTIS2023-506872-29-00招募中1 期
A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants with Alzheimer's Disease - AL002-LTE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Alector LLC
- 入组人数
- 347
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
- •The participant has completed the planned treatment period in the AL002-2 study. Completion of the planned treatment period is defined as any participant who did not prematurely and permanently discontinue the study drug in the AL002-2 study., Participant agrees not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study drug, Inclusion criteria for participants in the optional Tau PET imaging assessment with [18F]MK- 6240 only: Participant has not had excessive radiation exposure prior to enrollment in the trial, as defined by local standards., Inclusion criteria for participants in the optional Tau PET imaging assessment with [18F]MK- 6240 only: [18F]MK-6240 is available to the PET imaging center based on manufacturing distribution network and local regulations., Inclusion criteria for participants in the optional longitudinal Amyloid PET imaging assessment only: Participant has not had excessive radiation exposure prior to enrollment in the trial, as defined by local standards., Inclusion criteria for participants in the optional longitudinal Amyloid PET imaging assessment only: An approved amyloid radiotracer is available to the PET imaging center based on manufacturing distribution network and local regulations., The participant is willing and able to give informed consent. Where local regulations permit inclusion of participants deemed not able to provide informed consent, a legally authorized representative must provide informed consent on his or her behalf, and the participant must provide assent, in accordance with the local regulations, guidelines, and institutional review board or independent ethics committee., Female participants must be nonpregnant and nonlactating, and 1 of the following conditions must apply: a. Participant is not a woman of childbearing potential (WOCBP) (either surgically sterilized, or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal [amenorrhea duration of 12 consecutive months with no identified cause other than menopause]). b. Participant is a WOCBP and agrees to use an acceptable contraceptive method from screening until 12 weeks after the last dose of study drug. Acceptable contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom, or the sole sexual partner to a vasectomized male. Vasectomized males must have received medical assessment of surgical success. In addition, total abstinence, in accordance with the lifestyle of the participant, is acceptable. c. A WOCBP must have a serum pregnancy test conducted at screening. Additional requirements for pregnancy testing during and after study intervention are described in the Schedules of Assessments., Male participants must agree to use acceptable contraception and not donate sperm from screening until 12 weeks after the last dose of study drug. Acceptable contraception for the male participant when having sexual intercourse with a WOCBP who is not currently pregnant is defined as using a condom. In addition, WOCBP partners must use hormonal contraceptives or an intrauterine device. Vasectomized male participants should have received medical assessment of surgical success., Participant weighs =120 kg; body mass index (BMI) is between 18.5 and 34.9 kg/m2 inclusive., The participant has availability of a person (study p
排除标准
- •Participants deemed not able to provide consent or assent by the Investigator or by local regulations., Participants who were prematurely and permanently discontinued from IMP in the parent study for safety reasons., The participant has MRI evidence of: a. >2 lacunar infarcts. b. Any territorial infarct >1 cm^3. c. White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3. d. Participants who have an increase in their number of microbleeds, since the previous screening/ baseline MRI in the AL002-2 study and greater than 5, should be discussed with the Medical Monitor. e. Participants who have developed ARIA-E and ARIA-H in the parent study and who were permitted to continue dosing according to the ARIA management guidelines, will not be excluded from participation in the AL002-LTE, on the basis of microbleeds or hemosiderosis., Anticoagulant medications other than antiplatelet agents are prohibited within 90 days of screening and throughout the study. Short-term use of anticoagulants to treat an emergent medical need is permitted. Treatment with platelet anti-aggregation agents such as aspirin, clopidogrel, or dipyridamole is permitted., Participants taking any passive immunotherapy (eg, immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline., Participation in the AL002-LTE is deemed inappropriate for any reason per Investigator discretion., Participant agrees not to receive any investigational treatment, other than AL002, during the study.
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