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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Evaluation of safety and efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
Secondary outcome measures
Area under the curve concentration (AUC) for AL001
Maximum plasma concentration (Cmax) for AL001
Pharmacokinetics (PK) of AL001
Other outcome measures
Part 2: Assess the long-term safety and tolerability of IV administration of AL001 as measured by the CDR® plus NACC FTLD-SB

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
1,245 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved AL001 for public use?

"As this trial is at the Phase 2 stage, our team has assigned AL001 a safety score of 2; while some data exists to support its security profile, there are currently no results verifying efficacy."

Answered by AI

Does this investigation have any vacancies for participants?

"According to the clinicaltrials.gov website, this particular medical trial is not currently enrolling participants after being initially posted on September 27th 2019 and last edited a few months ago in June 28th 2022. Fortunately, there are still 423 other studies actively recruiting patients at present."

Answered by AI

In what geographical areas can individuals partake in this medical experiment?

"Presently, 6 sites are running this clinical trial - Philadelphia, Rochester and London among others. To ensure minimal commute time during the experiment, potential participants should consider selecting a location close to their home address."

Answered by AI

Who meets the criteria for enrolment in this medical experiment?

"This trial invites 40 participants, ranging from 18 to 85 years old in age and diagnosed with semantic dementia. Additionally, female enrollees must be nonpregnant and nonlactating; all applicants must possess healthy physical characteristics based on medical history reviews, PEs, laboratory tests, ECGs and vital signs readings; plus they need to carry either a GRN gene mutation or C9orf72 hexanucleotide repeat expansion mutation."

Answered by AI

Are adults aged 25 and above being admitted to partake in this research?

"This research requires participants to be aged 18-85. There are 30 studies for minors and 419 trials specifically targeting seniors."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

What questions have other patients asked about this trial?

How many times would I need to travel to the University of Pennsylvania ? And what percentage of people are on placebos ?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
2019. "A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03987295.
All > Semantic Dementia > Frontotemporal Dementia
~11 spots leftby Jan 2026
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