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NCT04374136 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
A Phase 3 study, sponsored by Alector.
- Terminated
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT04374136: Clinical Trial Phase 3 study, sponsored by Alector.
NCT04374136 is a Phase 3 study that was terminated before completion, run by Alector. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04374136, a Phase 3 study, was terminated before completion, sponsored by Alector.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.
Primary Outcome
The Clinical Dementia Rating Dementia Staging Instrument PLUS National Alzheimer's Disease Coordinating Center frontotemporal lobar degeneration Behavior \& Language Domains Sum of Boxes (CDR® plus NACC FTLD-SB) is administered by a healthcare professional and based on individual ratings of the eight domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care, language and behavior. Impairment is scored on a scale in which none = 0, questionable
Interventions
- DRUG Placebo
- DRUG AL001
- DRUG Open label - AL001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2026-01-06 |
| Phase | Phase 3 |
Why NCT04374136 stopped before completion
NCT04374136 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04374136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04374136 about?
NCT04374136 is a clinical study titled "A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)". A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.
What is the current status of trial NCT04374136?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2020-07-23. Estimated completion is 2026-01-06.
What interventions are being tested in trial NCT04374136?
The interventions under investigation include: Placebo (DRUG), AL001 (DRUG), Open label - AL001 (DRUG).
Who is sponsoring clinical trial NCT04374136?
This trial is sponsored by Alector, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04374136's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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