deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT02477800

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Sponsor: Biogen

Conditions Alzheimer's Disease
Interventions Aducanumab (BIIB037) Placebo
Updated 25 times since 2017 Last updated: Aug 9, 2021 Started: Aug 13, 2015 Primary completion: Aug 8, 2019 Completion: Aug 8, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed

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A PHASE3 clinical study on Alzheimer's Disease, this trial is terminated or withdrawn. The trial is conducted by Biogen and has accumulated 25 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Jun 2017 · 3 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Apr 2018 · 59 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~May 2019 · 8 months · monthly snapshot~May 2019 – ~Dec 2019 · 7 months · monthly snapshot~Dec 2019 – ~Sep 2020 · 9 months · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 8 months · monthly snapshot

Change History

25 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

▶ Show 20 earlier versions

  1. Oct 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  2. Jan 2021 — Oct 2021 [monthly]

    Terminated PHASE3

  3. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  4. Sep 2020 — Nov 2020 [monthly]

    Terminated PHASE3

  5. Dec 2019 — Sep 2020 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  6. May 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  9. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  10. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  11. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE3

  12. Feb 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

  13. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE3

  14. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  15. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  16. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  17. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  18. Mar 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  19. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  20. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Biogen
Data source: Biogen

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

Study Locations

Aachen, Germany , Aalborg, Denmark , Aizuwakamatsu-shi, Japan , Albany, United States , Amadora, Portugal , Asahikawa-shi, Japan , Atsugi-shi, Japan , Ballerup Municipality, Denmark , Barakaldo, Spain , Barcelona, Spain and 147 more locations