A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

STATUS

Recruiting
participants needed

180
sponsor

Alector Inc.

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Updated on 19 February 2024

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dementia

aphasia

pick's disease

progranulin

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 progranulin gene.

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 heterozygous mutations in the progranulin gene.

Details

Condition	Frontotemporal dementia, Pick's Disease
Age	18-85 years
Treatment	Placebo, AL001
Clinical Study Identifier	NCT04374136
Sponsor	Alector Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 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 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 Criteria
	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 unresolved cancer
	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

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Study Definition

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A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)