Trial · NCT03987295

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

NCT03987295, Phase 2, Completed, Alector Inc.; results first posted 2025-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2). Trials, record NCT03987295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03987295

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
NCT number: NCT03987295
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Alector Inc.
Conditions: Frontotemporal Dementia
Interventions: AL001
First posted: 2019-06-17
Last updated: 2025-12-05
Results first posted: 2025-08-22
Limitations and caveats: The study had the following limitations:~* No placebo control arm~* Small number of participants~* A high number of participants discontinued the study due to disease progression

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severity of TEAEs	197 weeks	Number of TEAEs categorized by severity
Primary	Severity of Treatment-Related TEAEs	197 weeks	Number of treatment-related TEAEs categorized by severity
Primary	Any TEAE Leading to Study Drug Discontinuation	197 weeks	Number of TEAEs leading to study drug discontinuation
Primary	Immunogenicity Antidrug Antibodies (ADA) Titer	97 weeks	Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study
Primary	Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses	97 weeks	Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).
Primary	Change From Baseline in Sheehan Suicidality Tracking Scale	197 weeks	The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.
Secondary	Longitudinal Percent Change From Baseline of CSF PGRN	97 weeks	The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.
Secondary	Longitudinal Percent Change From Baseline in Plasma PGRN	97 weeks	The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.
Secondary	Longitudinal Levels of Sortilin in WBCs	97 weeks	The overall change from baseline in Sortilin in WBCs.
Secondary	Latozinemab Concentration in Serum	97 weeks	Serum concentration of Latozinemab at week 97.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Severity of TEAEs	197 weeks	There is no statistical analysis for this primary end point.	TEAEs (all)	NUMBER
PRIMARY	Severity of Treatment-Related TEAEs	197 weeks	There is no statistical analysis for this primary end point.	TEAEs (treatment-related)	NUMBER
PRIMARY	Any TEAE Leading to Study Drug Discontinuation	197 weeks	There is no statistical analysis for this primary end point.	TEAE leading to discontinuation	NUMBER
PRIMARY	Immunogenicity Antidrug Antibodies (ADA) Titer	97 weeks	There is no statistical analysis for this primary end point.	Titers	MEDIAN
PRIMARY	Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses	97 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in Sheehan Suicidality Tracking Scale	197 weeks	There is no statistical analysis for this primary endpoint.	Scores	MEAN
SECONDARY	Longitudinal Percent Change From Baseline of CSF PGRN	97 weeks	There is no statistical analysis for this secondary end point.	percent change of ug/L	MEAN
SECONDARY	Longitudinal Percent Change From Baseline in Plasma PGRN	97 weeks	There is no statistical analysis for this secondary end point.	percent change in ug/L	MEAN
SECONDARY	Longitudinal Levels of Sortilin in WBCs	97 weeks	WBC samples for analysis for Sortilin expression were collected to serve as a pharmacodynamic biomarker of target engagement. Development of this assay found that stability of these samples was not reliable for accurate measurement. Hence, we did not measure Sortilin in this study.
SECONDARY	Latozinemab Concentration in Serum	97 weeks	There is no statistical analysis for this secondary end point.	ng/mL	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group93

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Severity of TEAEs	aFTD-GRN	Mild	43	TEAEs (all)
Severity of TEAEs	FTD-GRN	Mild	58	TEAEs (all)
Severity of TEAEs	FTD-C9orf72	Mild	84	TEAEs (all)
Severity of TEAEs	aFTD-GRN	Moderate	4	TEAEs (all)
Severity of TEAEs	FTD-GRN	Moderate	9	TEAEs (all)
Severity of TEAEs	FTD-C9orf72	Moderate	24	TEAEs (all)
Severity of TEAEs	aFTD-GRN	Severe	3	TEAEs (all)
Severity of TEAEs	FTD-GRN	Severe	1	TEAEs (all)
Severity of TEAEs	FTD-C9orf72	Severe	4	TEAEs (all)
Severity of TEAEs	aFTD-GRN	Life Threatening	0	TEAEs (all)

1 to 10 of 93Source ClinicalTrials.gov

See all 93 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	aFTD-GRN	5
Overall Study	STARTED	FTD-GRN	12
Overall Study	STARTED	FTD-C9orf72	16
Overall Study	COMPLETED	aFTD-GRN	5
Overall Study	COMPLETED	FTD-GRN	5
Overall Study	COMPLETED	FTD-C9orf72	6
Overall Study	NOT COMPLETED	aFTD-GRN	0
Overall Study	NOT COMPLETED	FTD-GRN	7
Overall Study	NOT COMPLETED	FTD-C9orf72	10

Source ClinicalTrials.gov

Adverse events441

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	aFTD-GRN	0	5	0
other	Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	FTD-GRN	1	12	1
other	Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	FTD-C9orf72	0	16	0
other	Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	aFTD-GRN	0	5
other	Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	FTD-GRN	1	12	1
other	Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	FTD-C9orf72	0	16	0
other	Diastolic hypertension	Vascular disorders	aFTD-GRN	0	5	0
other	Diastolic hypertension	Vascular disorders	FTD-GRN	0	12	0
other	Diastolic hypertension	Vascular disorders	FTD-C9orf72	1	16	1
other	Hypertension	Vascular disorders	aFTD-GRN	0	5	0

1 to 10 of 441Source ClinicalTrials.gov

See all 441 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	aFTD-GRN	0	5
Total, all-cause mortality	FTD-GRN	0	12
Total, all-cause mortality	FTD-C9orf72	1	16
Total, other adverse events	aFTD-GRN	4	5
Total, other adverse events	FTD-GRN	9	12
Total, other adverse events	FTD-C9orf72	13	16
Total, serious adverse events	aFTD-GRN	1	5
Total, serious adverse events	FTD-GRN	3	12
Total, serious adverse events	FTD-C9orf72	2	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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