A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
NCT ID: NCT03987295
Last Updated: 2025-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2019-09-27
2024-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Granulin and C9orf72
IV administration of AL001; 60 mg/kg, every 4 weeks \[q4w\]
AL001
60 mg/kg of AL001 every 4 weeks
Interventions
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AL001
60 mg/kg of AL001 every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
* Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation
Exclusion Criteria
* History of alcohol abuse or substance abuse
* Participant resides in a skilled nursing facility, convalescent home, or long term care facility
18 Years
85 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Alector Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Ljubenkov, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases UT Health San Antonio
San Antonio, Texas, United States
Lawson Health Research Institute, St. Joseph's
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Technical University of Munich
München, , Germany
University of Ulm
Ulm, , Germany
University of Brescia
Brescia, , Italy
Brain Research Center - PPDS
Amsterdam, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
University College London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AL001-2
Identifier Type: -
Identifier Source: org_study_id
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