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CompletedPhase 2Results posted

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

Lead sponsor

Alector Inc.

Asset

Latozinemab

Listed sites

12

Recruiting sites

-

Enrollment

33

actual

Study population

Frontotemporal dementia

Key I/E criterion

•GRN/C9orf72 mutation required

Primary endpoints

•Severity of TEAEs•Severity of Treatment-Related TEAEs•Any TEAE Leading to Study Drug Discontinuation

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 IDAL001-2
NCT IDNCT03987295

Timeline

Milestones

Study first posted2019-06-17actual
Study start2019-09-27actual
Primary completion2024-06-05actual
Study completion2024-06-05actual
Results first posted2025-08-22actual
Last update posted2025-12-05actual

Assets

Drug assets

Latozinemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•At screening, female participants must be nonpregnant and nonlactating
•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

•Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
•History of alcohol abuse or substance abuse
•Participant resides in a skilled nursing facility, convalescent home, or long term care facility

Endpoints (26)

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

Other (unclassified)
12
Safety / tolerability / PK
10
Behavior / neuropsychiatric
2
Fluid / digital biomarkers
2

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change From Baseline in Sheehan Suicidality Tracking Scale

Time frame:197 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Sheehan Suicidality Tracking Scale

Time frame:197 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ScoresStandard deviation
aFTD-GRNn=5 Participants00
FTD-GRNn=1 Participants0-
FTD-C9orf72n=3 Participants00

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Longitudinal Percent Change From Baseline of CSF PGRN

Time frame:97 weeks

percent change from baseline, improvement

Secondary/registry result

Longitudinal Percent Change From Baseline of CSF PGRN

Time frame:97 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change of ug/LStandard deviation
aFTD-GRNWeek 49n=4 Participants198.16110.255
Week 97n=4 Participants189.46113.802
FTD-GRNWeek 49n=8 Participants104.05103.349
Week 97n=2 Participants59.7324.034
FTD-C9orf72Week 49n=11 Participants101.6138.492
Week 97n=6 Participants144.7354.994

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Any TEAE Leading to Study Drug Discontinuation

Time frame:197 weeks

event count, event

Primary/protocol endpoint

Immunogenicity Antidrug Antibodies (ADA) Titer

Time frame:97 weeks

descriptive

Primary/protocol endpoint

Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses

Time frame:97 weeks

descriptive

Primary/registry result

Any TEAE Leading to Study Drug Discontinuation

Time frame:197 weeks

event count, event

Posted result

GroupValue (number), TEAE leading to discontinuationReported bounds
aFTD-GRNn=5 Participants0-
FTD-GRNn=12 Participants1-
FTD-C9orf72n=16 Participants1-
Primary/registry result

Immunogenicity Antidrug Antibodies (ADA) Titer

Time frame:97 weeks

descriptive

Posted result

GroupValue (median), TitersReported spread / bounds
aFTD-GRNWeek 2 - ADA Titern=5 Participants320.0-20 - 5120
Week 13 - ADA Titern=5 Participants160.0-20 - 2560
Week 25 - ADA Titern=5 Participants320.0-320 - 320
Week 37 - ADA Titern=5 Participants0-0 - 0
Week 49 - ADA Titern=5 Participants0-0 - 0
Week 61 - ADA Titern=5 Participants0-0 - 0
Week 73 - ADA Titern=5 Participants0-0 - 0
Week 85 - ADA Titern=5 Participants0-0 - 0
Week 97 - ADA Titern=5 Participants20.0-20 - 20
FTD-GRNWeek 2 - ADA Titern=12 Participants20.0-20 - 2560
Week 13 - ADA Titern=12 Participants160.0-160 - 640
Week 25 - ADA Titern=12 Participants330.0-20 - 640
Week 37 - ADA Titern=12 Participants80.0-20 - 320
Week 49 - ADA Titern=12 Participants320.0-40 - 640
Week 61 - ADA Titern=12 Participants0-0 - 0
Week 73 - ADA Titern=12 Participants160.0-160 - 160
Week 85 - ADA Titern=12 Participants160.0-160 - 160
Week 97 - ADA Titern=12 Participants0-0 - 0
FTD-C9orf72Week 2 - ADA Titern=16 Participants40.00.0020 - 160
Week 13 - ADA Titern=16 Participants120.0-80 - 160
Week 25 - ADA Titern=16 Participants80.0-20 - 160
Week 37 - ADA Titern=16 Participants90.0-20 - 160
Week 49 - ADA Titern=16 Participants20.0-20 - 20
Week 61 - ADA Titern=16 Participants160.0-160 - 160
Week 73 - ADA Titern=16 Participants0-0 - 0
Week 85 - ADA Titern=16 Participants20.0-20 - 20
Week 97 - ADA Titern=16 Participants160.0-160 - 160
Primary/registry result

Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses

Time frame:97 weeks

descriptive

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
aFTD-GRNADA Positiven=5 Participants1-
ADA Negativen=5 Participants4-
FTD-GRNADA Positiven=5 Participants0-
ADA Negativen=5 Participants5-
FTD-C9orf72ADA Positiven=9 Participants2-
ADA Negativen=9 Participants7-
Secondary/protocol endpoint

Cmax of Latozinemab at Specified Timepoints

Time frame:97 weeks

concentration, descriptive

Secondary/protocol endpoint

ARCmax of Latozinemab

Time frame:61 weeks

concentration, descriptive

Secondary/registry result

Cmax of Latozinemab at Specified Timepoints

Time frame:97 weeks

concentration, descriptive

Posted result

GroupValue (mean), ug/mLStandard deviation
aFTD-GRNn=5 Participants1810352
FTD-GRNn=2 Participants1320255
FTD-C9orf72n=7 Participants1510145
Secondary/registry result

ARCmax of Latozinemab

Time frame:61 weeks

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
aFTD-GRNn=5 Participants1.220.192
FTD-GRNn=8 Participants1.230.236
FTD-C9orf72n=10 Participants1.390.712

Other (unclassified)

12 endpoints
Primary/protocol endpoint/low confidence

Severity of TEAEs

Time frame:197 weeks

event count, event

Primary/protocol endpoint/low confidence

Severity of Treatment-Related TEAEs

Time frame:197 weeks

event count, event

Primary/registry result/low confidence

Severity of TEAEs

Time frame:197 weeks

event count, event

Posted result

GroupValue (number), TEAEs (all)Reported bounds
aFTD-GRNMildn=5 Participants43-
Moderaten=5 Participants4-
Severen=5 Participants3-
Life Threateningn=5 Participants0-
Deathn=5 Participants0-
FTD-GRNMildn=12 Participants58-
Moderaten=12 Participants9-
Severen=12 Participants1-
Life Threateningn=12 Participants0-
Deathn=12 Participants0-
FTD-C9orf72Mildn=16 Participants84-
Moderaten=16 Participants24-
Severen=16 Participants4-
Life Threateningn=16 Participants0-
Deathn=16 Participants1-
Primary/registry result/low confidence

Severity of Treatment-Related TEAEs

Time frame:197 weeks

event count, event

Posted result

GroupValue (number), TEAEs (treatment-related)Reported bounds
aFTD-GRNMildn=5 Participants5-
Moderaten=5 Participants1-
Severen=5 Participants0-
Life Threateningn=5 Participants0-
Deathn=5 Participants0-
FTD-GRNMildn=12 Participants1-
Moderaten=12 Participants1-
Severen=12 Participants0-
Life Threateningn=12 Participants0-
Deathn=12 Participants0-
FTD-C9orf72Mildn=16 Participants12-
Moderaten=16 Participants5-
Severen=16 Participants0-
Life Threateningn=16 Participants0-
Deathn=16 Participants0-
Secondary/protocol endpoint/low confidence

Longitudinal Percent Change From Baseline in Plasma PGRN

Time frame:97 weeks

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Longitudinal Levels of Sortilin in WBCs

Time frame:97 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Latozinemab Concentration in Serum

Time frame:97 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Ctrough of Latozinemab at Specified Timepoints

Time frame:97 weeks

concentration, descriptive

Secondary/registry result/low confidence

Longitudinal Percent Change From Baseline in Plasma PGRN

Time frame:97 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change in ug/LStandard deviation
aFTD-GRNWeek 49n=5 Participants177.3951.352
Week 97n=5 Participants185.3743.763
FTD-GRNWeek 49n=8 Participants151.3259.321
Week 97n=5 Participants188.1247.847
FTD-C9orf72Week 49n=11 Participants178.8258.406
Week 97n=9 Participants157.9392.695
Secondary/registry result/low confidence

Longitudinal Levels of Sortilin in WBCs

Time frame:97 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Latozinemab Concentration in Serum

Time frame:97 weeks

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
aFTD-GRNn=5 Participants23600069100
FTD-GRNn=2 Participants25000024700
FTD-C9orf72n=7 Participants26500077000
Secondary/registry result/low confidence

Ctrough of Latozinemab at Specified Timepoints

Time frame:97 weeks

concentration, descriptive

Posted result

GroupValue (mean), ug/mLStandard deviation
aFTD-GRNn=5 Participants23669.1
FTD-GRNn=2 Participants25024.7
FTD-C9orf72n=14 Participants25266.7

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.