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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    180
  • sponsor
    Alector Inc.
Updated on 16 October 2022
aphasia
dementia
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
Treatment Placebo, AL001, Open label - AL001
Clinical Study IdentifierNCT04374136
SponsorAlector Inc.
Last Modified on16 October 2022

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 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 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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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