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

Alector Inc.33 enrolled

Overview

A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Frontotemporal Dementia

Interventions

AL001DRUG

60 mg/kg of AL001 every 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (12)

UCSF

San Francisco, California, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Severity of TEAEs

Number of TEAEs categorized by severity

Time frame: 197 weeks

Severity of Treatment-Related TEAEs

Number of treatment-related TEAEs categorized by severity

Time frame: 197 weeks

Any TEAE Leading to Study Drug Discontinuation

Number of TEAEs leading to study drug discontinuation

Time frame: 197 weeks

Immunogenicity Antidrug Antibodies (ADA) Titer

Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study

Time frame: 97 weeks

Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses

Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).

Time frame: 97 weeks

Change From Baseline in Sheehan Suicidality Tracking Scale

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.

Time frame: 197 weeks

Secondary Outcomes

Data from ClinicalTrials.gov

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