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AL001 for Frontotemporal Dementia

Phase 3
Waitlist Available
Led By Peter Ljubenkov, MD
Research Sponsored by Alector Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Must not have
History of cancer within the last 5 years.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing AL001, a drug given through an IV, to see if it can help people with a genetic mutation that causes frontotemporal dementia. The goal is to find out if AL001 can improve brain health in these individuals.

Who is the study for?
This trial is for people with a specific gene mutation linked to frontotemporal dementia (FTD), including those at risk of developing FTD or diagnosed with it. Participants need a study partner available for support, and they must not be pregnant, planning pregnancy, or have significant heart, liver, kidney diseases, uncontrolled diabetes or hypertension.
What is being tested?
The trial tests the safety and effectiveness of AL001 in treating FTD compared to a placebo. Some participants will receive AL001 openly. It's designed as a phase 3 double-blind study where neither the researchers nor participants know who gets the real treatment versus placebo.
What are the potential side effects?
While specific side effects are not listed here, similar treatments often cause reactions at injection sites, allergic responses to components of the drug (like chimeric antibodies), and may affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a progranulin gene mutation and am at risk of or have been diagnosed with FTD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer in the past 5 years.
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I do not have uncontrolled high blood pressure, diabetes, thyroid, heart, liver, or kidney disease, and no significant brain disease other than FTD.
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I am not pregnant, breastfeeding, nor planning to conceive during the study.
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I have not received any experimental vaccines or gene therapy.
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I live in a care facility or need constant nursing care.
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I am currently taking blood thinners.
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My dementia is not caused by frontotemporal dementia (FTD) but another condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
Secondary study objectives
Change in Clinical Global Impression-Improvement (CGI-I) Score
Change in Clinical Global Impression-Severity (CGI-S) Score
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
+2 more
Other study objectives
Optional Open-Label Extension

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open label - AL001Experimental Treatment1 Intervention
AL001 every 4 weeks
Group II: AL001Experimental Treatment1 Intervention
AL001 every 4 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL001
2018
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Alector Inc.Lead Sponsor
10 Previous Clinical Trials
1,153 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
104 Patients Enrolled for Frontotemporal Dementia
Peter Ljubenkov, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
119 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
104 Patients Enrolled for Frontotemporal Dementia
TBD TBDPrincipal Investigator
6 Previous Clinical Trials
1,492 Total Patients Enrolled

Media Library

AL001 Clinical Trial Eligibility Overview. Trial Name: NCT04374136 — Phase 3
Frontotemporal Dementia Research Study Groups: Open label - AL001, Placebo, AL001
Frontotemporal Dementia Clinical Trial 2023: AL001 Highlights & Side Effects. Trial Name: NCT04374136 — Phase 3
AL001 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374136 — Phase 3
Frontotemporal Dementia Patient Testimony for trial: Trial Name: NCT04374136 — Phase 3
~16 spots leftby Sep 2025
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