A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene. - NA

Alector Inc.0 个研究点目标入组 180 人开始时间: 2021年6月15日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•Known progranulin genetic mutation causing FTD.
•CDR plus NACC-FTLD score 0-2.
•If symptomatic, one of the criteria for the diagnosis of probable behavioral variant FTD or FTD-semantic subtype or FTD-Progressive Nonfluent Aphasia.
•Study partner who consents to study participation and who cares for/visits the patient daily for at least 5 hours per week.
•Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from their legal decision maker).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 144
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies,
•Huntington disease, or vascular dementia.
•Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
•Current uncontrolled hypertension, diabetes mellitus or thyroid disease.
•Clinically significant heart disease, liver disease or kidney disease.
•History or evidence of clinically significant brain disease other than FTD.
•Females who are pregnant or breastfeeding, or planning to conceive within the study period.
•Any experimental vaccine or gene therapy.
•History of cancer except:
•If considered to be cured
•If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the investigator, not likely to require treatment in the ensuing 3 years
•Is considered to have low probability of recurrence
•For prostate cancer, no significant progression over the previous 2 years
•Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
•Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.

发起方