Monitoring Cogniton in the ECT-AD Study: Methodological Paper

Out on PubMed, from a consortium of US investigators, is this paper:

A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study.

Park S, Forester BP, Lapid MI, Harper DG, Hermida AP, Inouye SK, McClintock SM, Nykamp L, Petrides G, Schmitt EM, Seiner SJ, Mueller M, Patrick RE.J Geriatr Psychiatry Neurol. 2023 Oct 17:8919887231207641. doi: 10.1177/08919887231207641. Online ahead of print.PMID: 37848185


The abstract is copied below:

Objective: To develop an individualized method for detecting cognitive adverse events (CAEs) in the context of an ongoing trial of electroconvulsive therapy for refractory agitation and aggression for advanced dementia (ECT-AD study).

Methods: Literature search aimed at identifying (a) cognitive measures appropriate for patients with advanced dementia, (b) functional scales to use as a proxy for cognitive status in patients with floor effects on baseline cognitive testing, and (c) statistical approaches for defining a CAE, to develop CAEs monitoring plan specifically for the ECT-AD study.

Results: Using the Severe Impairment Battery-8 (SIB-8), baseline floor effects are defined as a score of ≤5/16. For patients without floor effects, a decline of ≥6 points is considered a CAE. For patients with floor effects, a decline of ≥30 points from baseline on the Barthel Index is considered a CAE. These values were derived using the standard deviation index (SDI) approach to measuring reliable change.

Conclusions: The proposed plan accounts for practical and statistical challenges in detecting CAEs in patients with advanced dementia. While this protocol was developed in the context of the ECT-AD study, the general approach can potentially be applied to other interventional neuropsychiatric studies that carry the risk of CAEs in patients with advanced dementia.

Keywords: Alzheimer’s disease; cognition; dementia; electroconvulsive therapy; safety.

The paper is here.
And from the text:




This is an interesting and detailed paper dealing with the methodology of assessing cognitive change in a cohort of patients with advanced dementia. It is very clearly presented and could be quite useful for other researchers in the field.
 It is also very relevant as a reminder of the ECT-AD study, and the development of the novel indication for ECT to treat agitation/aggression in dementia.

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