TerminatedPhase 3

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

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

Lead sponsor

Alector Inc.

Asset

Latozinemab

Listed sites

Recruiting sites

Enrollment

119

actual

Study population

Frontotemporal dementia

Key I/E criteria

•At-risk or symptomatic FTD•GRN mutation required•Study partner/caregiver required•Current anticoagulant use excluded

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAL001-3

NCT IDNCT04374136

Timeline

Milestones

Study first posted2020-05-05actual

Study start2020-07-23actual

Primary completion2025-09-01actual

Study completion2026-01-06actual

Last update posted2026-01-21actual

Assets

Drug assets

Latozinemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age25 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Other clinical outcomes

Neurodegeneration biomarkers

Global cognition

2 endpoints

Primary/protocol endpoint

Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB

Time frame:Through study completion, on average up to 96 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

ratio, descriptive

Secondary/protocol endpoint

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

Time frame:Baseline to 96 weeks

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Pharmacodynamic Biomarkers

Time frame:Baseline to 96 weeks

Neurofilament light (NfL)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Evaluation of safety and tolerability of AL001: Incidence of adverse events

Time frame:Baseline to 96 weeks

event count, event

Other/protocol endpoint

Optional Open-Label Extension

Time frame:96 weeks

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change in Clinical Global Impression-Severity (CGI-S) Score

Time frame:Baseline to 96 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Clinical Global Impression-Improvement (CGI-I) Score

Time frame:Baseline to 96 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.