ECT For Agitation In Dementia: Evolution Of the ECT-AD Trial Methodology

 Out on PubMed, from researchers across the US, is this paper:

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol.

Lapid MI, Merrill J, Mueller M, Hermida AP, Nykamp L, Andrus J, Azizi H, Bolton P, Bonsu N, Braga R, Dillon CR, Ecklesdafer D, Evans D, Harper D, Heintz H, Hussain-Krauter S, Holzgen O, Humphrey D, Jiwani S, Johnson EK, Kang S, Kassien J, Kim J, Knapp RG, Kung S, Kremen N, Le K, Mahdasian J, Marzouk T, Masrud JD, Mattingly J, Miller D, Pagali SR, Patrick R, Riva Posse P, Pritchett C, Rahman A, Rath S, Roczniak C, Rummans TA, Sanghani S, Seiner S, Smart L, Tomaschek E, Tsygankova V, VanderSchuur-White L, Walton MP, Wilkins J, Williams A, Williams SM, Petrides G, Forester BP.PLoS One. 2024 Jun 28;19(6):e0303894. doi: 10.1371/journal.pone.0303894. eCollection 2024.PMID: 38941338 

The abstract is copied below:

Objective: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented.

Methods: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants.

Results: Study is ongoing and open to enrollment.

Conclusion: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

The paper is here.

And from the text:

The ECT-AD trial is an important effort to study the role of ECT in the treatment of severe aggression and agitation in dementia. This paper chronicles the real-world challenges of carrying out such research, and the adaptive response of the team of academic collaborators. The evolved study design, now open label, will provide extremely valuable data to guide the field. Kudos to this team of investigators who have demonstrated such perseverance and resilience.