# A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia (ECT-AD)

> **NIH NIH R01** · MCLEAN HOSPITAL · 2020 · $2,344,010

## Abstract

ABSTRACT
Alzheimer's dementia (AD), the most prevalent neurodegenerative disease of aging, affects cognition,
emotion, and behavior. Agitation is a common behavioral syndrome that frequently emerges during middle
to late stage AD and is characterized by psychomotor hyperactivity, aggression, irritability, yelling, resistance
to care, and insomnia. The untoward consequences of agitation and related behavioral disturbances are
considerable and include impaired quality of life, accelerated cognitive decline, heightened risk of
institutionalization, and increased morbidity and mortality. Agitation also increases caregiver burden,
including stress and deleterious health consequences. However, despite the damaging impact of agitation
on the patient and caregiver, current treatments have only modest efficacy. Behavior management strategies
are widely employed, but effective only in mild cases. Antipsychotics, the most commonly used class of
medication for agitation and psychosis in dementia, have demonstrated mixed results in controlled studies
and are associated with elevated morbidity and mortality. Thus, there is a clear need for improved
interventions, particularly for severe agitation in AD.
Electroconvulsive Therapy (ECT) is a safe and effective intervention for severe mood disorders in later
life, including depression complicated by psychosis, mania or catatonia. Concerns regarding adverse cognitive
effects of ECT, however, have limited ECT's clinical use in treating dementia with agitation. Both retrospective
and prospective studies conducted by our group support the safety and efficacy of ECT in patients with AD
and severe agitation. ECT, therefore, may represent an effective treatment of severe agitation in AD. We
propose a five-site, randomized, single-blind, controlled clinical trial to determine the safety and efficacy of
ECT plus usual care compared with Simulated ECT (S-ECT) plus usual care in 200 hospitalized
individuals with moderate to severe stage AD , probable Alzheimer's type (based on NIA-AA criteria),
complicated by severe agitation. Subjects will be randomized to either (1) ECT for three weeks (up to 9 ECT
treatments) plus usual care (UC), defined as standard behavioral therapy and pharmacotherapy or (2) Simulated
ECT (S-ECT) plus UC. Primary efficacy will be measured with the Cohen-Mansfield Agitation Inventory (CMAI).
Safety parameters include daily assessment of delirium (Confusion Assessment Method, CAM), cognition
(Severe Impairment Battery, SIB-8) and serious adverse events. A 12-week follow-up includes monthly
assessments to explore stability of agitation reduction.

## Key facts

- **NIH application ID:** 9969291
- **Project number:** 5R01AG061100-03
- **Recipient organization:** MCLEAN HOSPITAL
- **Principal Investigator:** Brent Peter Forester
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,344,010
- **Award type:** 5
- **Project period:** 2018-09-30 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969291

## Citation

> US National Institutes of Health, RePORTER application 9969291, A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia (ECT-AD) (5R01AG061100-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969291. Licensed CC0.

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