deltatrials
Recruiting INTERVENTIONAL NCT03926520

Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) (ECT-AD)

Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia

Sponsor: Brent Forester

Updated 13 times since 2019 Last updated: Apr 24, 2026 Started: Jan 28, 2021 Primary completion: May 31, 2026 Completion: May 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Agitation,Psychomotor and Alzheimer Dementia and is currently actively recruiting participants. Brent Forester leads this study, which shows 13 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.

This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.

Status Flow

~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~May 2022 · 12 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Nov 2023 · 16 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2026 · 20 months · monthly snapshotMay 4, 2026 – present · 49 days · daily API

Change History

13 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Sep 2024 — May 2026 [monthly]

    Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  4. Nov 2023 — Jul 2024 [monthly]

    Recruiting NA

  5. Jul 2022 — Nov 2023 [monthly]

    Recruiting NA

Show 8 earlier versions
  1. May 2022 — Jul 2022 [monthly]

    Recruiting NA

  2. May 2021 — May 2022 [monthly]

    Recruiting NA

  3. Mar 2021 — May 2021 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  4. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting NA

  5. Feb 2020 — Jan 2021 [monthly]

    Not Yet Recruiting NA

  6. Aug 2019 — Feb 2020 [monthly]

    Not Yet Recruiting NA

  7. Jul 2019 — Aug 2019 [monthly]

    Not Yet Recruiting NA

  8. May 2019 — Jul 2019 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.

Contact Information

Sponsor contact:
  • Brent Forester
  • Emory University
  • Mayo Clinic
  • Medical University of South Carolina
  • Pine Rest Christian Mental Health Services
  • The Zucker Hillside Hospital
Data source: ClinicalTrials.gov

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