NCT04374136Phase 3Terminated

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

Study sponsor: Alector Inc. · ALEC

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-09-01Actual
Enrollment · participants119Actual
Source updated2026-09-21Last update listed in the registry record
Version history

Changes to this trial

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· 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance
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measure: Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB

+ Updated value

measure: Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients; measure: Part 1 Double Blind (Co-Primary US Endpoint) - Evaluation of the Treatment Effect of AL001 Compared With Placebo as Measured by Pharmacodynamic and Disease Pathology Biomarkers in Symptomatic Patients; measure: Part 2 OLE - To Assess the Long-term Safety and Tolerability of AL001 in Participants Who Have Completed Part 1 of the Study

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· 4 fields changed

Participant count type

Recorded edit
− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit
− Previous value

count: 110; type: ESTIMATED

+ Updated value

count: 119; type: ACTUAL

Completion date type

Recorded edit
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Estimated

+ Updated value

Actual

Recruitment status

Recorded edit
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Active not recruiting

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Terminated

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