deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT01862640

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Sponsor: H. Lundbeck A/S

Conditions Agitation Associated With Alzheimer's Disease Alzheimer's Type Mental Disorder Nervous System Diseases
Interventions Brexpiprazole, OPC-34712 Placebo Oral Tablet
Updated 14 times since 2017 Last updated: Dec 8, 2020 Started: Jul 11, 2013 Primary completion: Mar 15, 2017 Completion: Mar 15, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Agitation Associated With and Alzheimer's Disease and is currently completed. H. Lundbeck A/S leads this study, which shows 14 recorded versions since 2013 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Feb 2018 · 6 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~Apr 2020 · 12 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 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 · 7 months · monthly snapshot

Change History

14 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 9 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  2. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Apr 2020 — Jul 2020 [monthly]

    Completed PHASE3

  4. Apr 2019 — Apr 2020 [monthly]

    Completed PHASE3

  5. Jun 2018 — Apr 2019 [monthly]

    Completed PHASE3

  6. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE3

  7. Aug 2017 — Feb 2018 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  8. Feb 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  9. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • H. Lundbeck A/S
  • Otsuka Pharmaceutical Development & Commercialization, Inc.
Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Study Locations

Achim, Germany , Barcelona, Spain , Bedford, United States , Belgrade, Serbia , Bellflower, United States , Berlin, Germany , Bielefeld, Germany , Bochum, Germany , Coconut Creek, United States , Cologne, Germany and 56 more locations