deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT05256134

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD) (SKYLINE)

A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

Sponsor: Hoffmann-La Roche

Updated 15 times since 2022 Last updated: May 30, 2025 Started: Apr 19, 2022 Primary completion: Mar 13, 2023 Completion: Mar 13, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Decision to terminate development of gantenerumab for treatment of people at risk for or at earliest stages of Alzheimer disease (AD) following results of a pre-planned analysis of safety \& efficacy of gantenerumab in Graduate I\&II (WN29922/WN39658).

Listed as NCT05256134, this PHASE3 trial focuses on Alzheimers Disease and remains terminated or withdrawn. Sponsored by Hoffmann-La Roche, it has been updated 15 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~May 2023 · 4 months · monthly snapshot~May 2023 – ~Jul 2024 · 14 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

15 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Jul 2025 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Sep 2024 — Jul 2025 [monthly]

    Terminated PHASE3

  4. Aug 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Jul 2024 — Aug 2024 [monthly]

    Terminated PHASE3

Show 10 earlier versions
  1. May 2023 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

  2. Jan 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  3. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  4. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  5. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  6. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  7. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  8. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  9. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  10. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

For direct contact, visit the study record on ClinicalTrials.gov .