deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT02817906

ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

Sponsor: Intra-Cellular Therapies, Inc.

Interventions ITI-007 Placebo
Updated 13 times since 2017 Last updated: Jun 8, 2021 Started: Aug 29, 2016 Primary completion: Jan 30, 2019 Completion: Jan 30, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Pre-specified Interim Analysis Indicated Futility

Other terminated trials from Intra-Cellular Therapies, Inc.

More terminations from Intra-Cellular Therapies, Inc.

This PHASE3 trial investigates Agitation in Dementia, Including Alzheimer's Disease and is currently terminated or withdrawn. Intra-Cellular Therapies, Inc. leads this study, which shows 13 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Sep 2017 · 5 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 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 – present · 12 months · monthly snapshot

Change History

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

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE3

Show 8 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Terminated PHASE3

  2. Jan 2019 — Jan 2021 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  3. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  4. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  5. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  6. Apr 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  7. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intra-Cellular Therapies, Inc.
Data source: Intra-Cellular Therapies, Inc.

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