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NCT04374136 (AL001 in Frontotemporal Dementia due to a progranulin…): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 21 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04374136
Acronym
INFRONT-3
Drug Name
AL001
Drug MoA
anti-SORT1 inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Frontotemporal Dementia due to a progranulin gene mutation (FTD-GRN)
Human Patients
110
Sponsor
Alecto
Phase
Phase 3

Prediction of , index 579

Prospective Prediction
Prediction Index
579
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in CDR + NACC FTLD-SB)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in CDR + NACC FTLD-SB compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
85 days in advance
Readout Data Interpretation
AL001 failed to meet the primary endpoint of slowing FTD-GRN progression
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene
Phase
Phase 3
Status
Terminated
Enrollment
119
Lead sponsor
Alector Inc.
Conditions
Frontotemporal Dementia
Interventions
DRUG: Part 1 Blinded - AL001; DRUG: Part 1 Blinded - Placebo; DRUG: Part 2 (OLE Treatment) - AL001; DRUG: Part 2 (OLE Treatment) - Placebo Switched to AL001
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-07-23
Primary completion
2025-09-01
Completion
2026-01-06
Results first posted
2026-09-21
Primary outcomes
  • Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients (Through study completion, on average up to 96 weeks)
  • 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 (Baseline to 96 weeks)
  • Part 2 OLE - To Assess the Long-term Safety and Tolerability of AL001 in Participants Who Have Completed Part 1 of the Study (96 weeks)

NCT04374136 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials