NL-OMON52800招募中2 期
A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia - An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD
Alector Inc0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
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 99（—）
入选标准
- •Part 1: Protspective participants must meet all of the following criteria
- •specific to their
- •applicable participant category. These bullet points are some of the
- •important criteria within each category:
- •1) Completed Study AL001-1 through the Day 57 visit and did
- •not experience AEs that the investigator deems would prevent safe
- •participation in Study AL001-2.
- •2) Meets 1 or more of the 6 behavioral/cognitive symptoms
- •required for a diagnosis of possible behavioral variant frontotemporal
- •dementia (bvFTD; Rascovsky 2011) or has diagnosis of primary
- •progressive aphasia (PPA; Gorno Tempini 2011)
- •3) Prospective participant is a carrier of a loss of function GRN mutation
- •causative of
- •4) Is a carrier of a hexanucleotide repeat expansion C9orf72
- •mutation causative of FTD and knows their mutation status
- •5) Has a CDR® plus NACC global score of 0.5, 1, or 2; and 1 or
- •more of the 6 behavioral/cognitive symptoms required for a diagnosis of
- •possible bvFTD (Rascovsky 2011) or a diagnosis of PPA (Gorno Tempini
- •In addition, this is the list of the important inclusion criteria:
- •Participants are 18 to 85 years of age.
- •At screening, female prospective participants must be nonpregnant and
- •nonlactating, and at least one of the following conditions must apply:
- •- 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]).
- •- Participant is a WOCBP and using an acceptable contraceptive method
- •from screening until 8 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. In addition,
- •total abstinence, in accordance with the lifestyle of the participant, is
- •acceptable.
- •- A WOCBP must have a serum pregnancy test conducted at screening.
- •Additional requirements for pregnancy testing during and after final dose of
- •intervention are located in the Schedules of Assessments (Table 14-1 and table
- •the protocol).
- •Male prospective participants, if not surgically sterilized, must agree to use
- •acceptable contraception and not donate sperm from Day 1 until 10 weeks
- •after the last dose of study drug. Acceptable contraception for the male
- •patient when having sexual intercourse with a WOCBP who is not currently
- •pregnany is defined as using a condom. In addition, WOCBP partners must use
- •contraceptives or an intrauterine device combined with at least 1 of the
- •following forms of contraception: a diaphragm or cervical cap, or a
- •condom. In addition, total abstinence, in accordance with the lifestyle of
- •the participant, is acceptable.
- •Agrees not to donate blood or blood products for
- •transfusion for the duration of the study and for 1 year after final dose of
- •study drug.
- •Is willing and has the ability to comply with the study
- 另有 4 项未显示
排除标准
- •History of severe allergic, anaphylactic, or
- •other hypersensitivity reactions to chimeric, human, or humanized
- •antibodies or fusion proteins.
- •History of substance use disorder (drug or alcohol)
- •within the past 2 years, with the exception of nicotine, as defined by the
- •Diagnostic and Statistical Manual of Mental Disorders, fifth edition
- •criteria (American Psychiatric Association 2013).
- •Current acute illness or active infection requiring oral or IV antibiotics
- •within 30 days prior to study drug
- •administration that may affect safety assessments.
- •History of surgery, hospitalization, or clinically significant
- •infection requiring oral or IV antibiotics during the 30 days prior to
- •Has planned procedure or surgery during the study that
- •would interfere with the ability to perform study assessments.
- •History of seizures, with the exception of
- •childhood febrile seizures.
- •Has clinically, significant systemic immunocompromised
- •condition because of continuing effects of immune suppressing
- •medication.
- •Has major depressive disorder or history of schizophrenia,
- •schizoaffective disorder, or bipolar disorder.
- •Has history of cancer
- •Has history or presence of intracranial tumor that is
- •clinically relevant.
- •Has any clinically significant medical condition or
- •laboratory abnormality that precludes the participant's safe participation
- •in and completion of the study.
- •Positive for hepatitis B surface antigen, hepatitis C virus
- •antibodies, or human immunodeficiency virus 1 and 2 antibodies or
- •antigen, or history of spirochetal infection of the CNS.
- •Significant kidney disease as indicated by a screening
- •creatinine clearance <30 mL/min as calculated by the central laboratory
- •using the Cockcroft Gault formula, which remains <30 mL/min if
- •Impaired hepatic function as indicated by screening
- •aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=
- •2.5 the upper limit of normal (ULN) or total bilirubin >=2.0 × ULN, which
- •remains above either of these limits if retested or other abnormalities in
- •synthetic function that are clinically significant.
- •Has, within the last 2 years, had unstable or clinically
- •significant cardiovascular disease.
- •Participant has uncontrolled hypertension.
- •Participant has history or presence of an abnormal ECG that is
- •clinically significant including complete left bundle branch block,
- •secondor third degree heart atrioventricular block, or evidence of prior
- •acute or subacute myocardial infarction or ischemia.
- •Participant has QT interval corrected using Fridericia formula (QTcF)
- •Related Exclusion Criteria please refer to the protocol
- •Part 1 participants are not eligible for continued treatment with AL001
- •optional OLE if any of the following apply:
- •1. Part 1 participant has been admitted to a skilled nursing facility,
- 另有 6 项未显示
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