EUCTR2019-004066-18-DE
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Frontotemporal Dementia
- Sponsor
- Alector Inc.
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Is a known carrier of a heterozygous loss\-of\-function GRN mutation causative of FTD with a global CDR® plus NACC FTLD score of 0 to 2, and:
- •A CDR® plus NACC FTLD\-SB score \=0\.5 with an elevated level of serum NfL, or
- •A CDR® plus NACC FTLD\-SB score of \>0\.5 with 1 or more of the 6 behavioral/cognitive symptoms required for a diagnosis of possible bvFTD
- •(Rascovsky 2011\), or a diagnosis of PPA
- •2\. Age 25 to 85 years, inclusive, at Screening
- •3\. At Screening, women must be nonpregnant and nonlactating, and one of the following conditions must apply:
- •a. 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. Is a WOCBP and agrees to use an acceptable contraceptive method from Screening until 10 weeks after the last dose of study treatment. Acceptable contraception is defined as using hormonal contraceptives (e.g. combined oral contraceptive pill) 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, if 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.
- •4\. Men must agree to use acceptable contraception and not donate sperm from Day 0 until 10 weeks after the last dose of study treatment. 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 (e.g. combined oral contraceptive pill) or an intrauterine device.
Exclusion Criteria
- •1\. Dementia due to a condition other than FTD including, but not limited to, Alzheimer’s disease, Parkinsonism, REM behavior disorder, dementia with Lewy bodies, Huntington disease, or vascular dementia.
- •2\.Known mutation causative of neurodegenerative disorder(s) other than heterozygous loss\-of\-function GRN mutations causative of FTD.
- •3\.Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- •4\. Signs or symptoms of progressive supranuclear palsy or bulbar dysfunction, such as postural instability, eye problems, and swallowing difficulties.
- •5\. History of moderate or severe substance use disorder within the past 2 years, with the exception of nicotine, as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria
- •6\. Clinically significant vitamin B12 or folate deficiency (if treated, must be on a stable regimen for at least 3 months prior to first study treatment administration).
- •7\.Untreated hypothyroidism (if treated, thyroid supplementation dose must be stable for at least 3 months with a normal thyroid\-stimulating hormone level prior to study treatment administration).
- •8\.Insufficiently controlled diabetes mellitus (e.g., hemoglobin A1C \=8%).
- •9\.Any surgery (major or emergent) or hospitalization within 30 days prior to first study treatment administration.
- •10\. History of cancer within the last 5 years with the exception of basal cell or squamous cell carcinoma.
Outcomes
Primary Outcomes
Not specified
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