Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
Lead Sponsor:
Alector Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Frontotemporal Dementia
Eligibility:
All Genders
25-85 years
Phase:
PHASE3
Brief Summary
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranuli...
Detailed Description
This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heter...
Eligibility Criteria
Inclusion
- Persons with a progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker, or persons with a progranulin gene mutation and diagnosed with FTD.
- If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia.
- Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Exclusion
- 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 within the last 5 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.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 3 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04374136
Start Date
July 23 2020
End Date
August 3 2027
Last Update
August 5 2025
Active Locations (44)
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1
Dignity Health
Phoenix, Arizona, United States, 85013
2
University of California San Diego
La Jolla, California, United States, 92093-0648
3
University of Colorado
Aurora, Colorado, United States, 80045
4
Emory University
Atlanta, Georgia, United States, 30329