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Monoclonal Antibodies

AL001 for Frontotemporal Dementia

Phase 2
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a possible new treatment for frontotemporal dementia, which is a degenerative brain disease.

Who is the study for?
This trial is for individuals in good physical health who have specific genetic mutations (GRN or C9orf72) linked to frontotemporal dementia. Women must not be pregnant or breastfeeding. Excluded are those living in long-term care facilities, with a history of substance abuse, or severe allergies to certain antibodies.
What is being tested?
The study tests the safety and effects of AL001 on patients with frontotemporal dementia due to GRN or C9orf72 mutations. It's an open-label Phase 2 trial, meaning everyone gets the drug and both researchers and participants know what's being administered.
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at the injection site, headaches, nausea, fatigue, allergic responses to the antibody treatment used in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good health with no significant medical issues found in recent exams or tests.
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I carry a specific genetic mutation linked to certain neurological conditions.
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I am not pregnant or breastfeeding.

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
Part 1: Evaluation of safety and efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
Secondary study objectives
Area under the curve concentration (AUC) for AL001
Maximum plasma concentration (Cmax) for AL001
Pharmacokinetics (PK) of AL001
Other study objectives
Part 2: Assess the long-term safety and tolerability of IV administration of AL001 as measured by the CDR® plus NACC FTLD-SB

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: GranulinExperimental Treatment1 Intervention
IV administration of AL001; 60 mg/kg, every 4 weeks \[q4w\]
Group II: C9orf72Experimental Treatment1 Intervention
IV administration of AL001; 60 mg/kg, every 4 weeks \[q4w\]
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
1,223 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
174 Patients Enrolled for Frontotemporal Dementia
Peter Ljubenkov, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
189 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
174 Patients Enrolled for Frontotemporal Dementia

Media Library

AL001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03987295 — Phase 2
Frontotemporal Dementia Research Study Groups: C9orf72, Granulin
Frontotemporal Dementia Clinical Trial 2023: AL001 Highlights & Side Effects. Trial Name: NCT03987295 — Phase 2
AL001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03987295 — Phase 2
~7 spots leftby Jan 2026
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