AL001 for Frontotemporal Dementia

Recruiting in Palo Alto (17 mi)

+68 other locations

Overseen byTBD TBD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alector Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.

Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

I have a progranulin gene mutation and am at risk of or have been diagnosed with FTD.

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Exclusion Criteria

You have had severe allergic reactions to certain types of medications made from human or animal proteins.

I have had cancer in the past 5 years.

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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Treatment Details

Interventions

AL001 (Progranulin Stabilizer)
Placebo (Drug)

Trial OverviewThe 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.

Participant Groups

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