deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04770220

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

Sponsor: Alzheon Inc.

Updated 18 times since 2021 Last updated: Oct 23, 2025 Started: May 19, 2021 Primary completion: May 29, 2024 Completion: Jul 29, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Early Alzheimer's Disease, this trial is completed. The trial is conducted by Alzheon Inc. and has accumulated 18 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~Feb 2024 · 10 months · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

18 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Jun 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

Show 13 earlier versions
  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Apr 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Apr 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  6. Sep 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  7. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  8. Apr 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  9. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  10. Dec 2021 — Mar 2022 [monthly]

    Recruiting PHASE3

  11. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  12. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  13. Mar 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alzheon Inc.
  • National Institute on Aging (NIA)
Data source: Alzheon Inc.

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