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NCT04639050 (Trontinemab in Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 15 Sep 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. 2 readouts followed: 30 Oct 2024, True Positive (TP); 1 Dec 2025, True Negative (TN).

Clinical Trial

NCTID
NCT04639050
Acronym
Brainshuttle AD
Drug Name
Trontinemab (RO7126209)
Drug MoA
bispecific anti-abeta and anti-TfR1 antibody
Drug Modality
bispecific antibody
Drug Class
Best-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Alzheimer's Disease
Human Patients
241
Sponsor
Roche
Phase
Phase 1 Phase 2

Prediction of , index 1788

Prospective Prediction
Prediction Index
1788
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in CDR-SB/ADAS-Cog13 inferior to lecanemab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in brain amyloid load reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
45 days in advance
Readout Data Interpretation
trontinemab achieved strong effect in amyloid load reduction at week 28 (-107 CL at 3.6 mg/kg vs -3 CL in placebo); no data available for CDR-SB/ADAS-Cog13
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (in amyloid beta reduction) and commercially TBD (wait for CDR-SB/ADAS-Cog13 data)
Prediction Classification
True Positive (TP)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
442 days in advance
Readout Data Interpretation
trontinemab achieved statistically insignificant 0.15-0.20 placebo-adjusted CDR-SB score improvement at month 6, which is inferior to the statistically significant -0.17 placebo-adjusted CDR-SB score improvement at month 6 (p<0.01) achieved by lecanemab (see add'l link below); Trontinemab achieved 81% amyloid-negative within 6 months at 3.6 mg/kg dose
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient (inferior to lecanemab)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase Ib/IIa, Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Patients With Prodromal or Mild to Moderate Alzheimer's Disease
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
241
Lead sponsor
Hoffmann-La Roche
Conditions
Alzheimers Disease
Interventions
DRUG: RO7126209; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2021-03-15
Primary completion
2027-07-31
Completion
2027-07-31
Primary outcomes
  • Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs) (Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks)
  • Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan (Up to approximately 24 weeks)

NCT04639050 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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