Actively Recruiting
Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
Led by Brent Forester · Updated on 2026-04-28
50
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Brent Forester
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Electroconvulsive Therapy (ECT) combined with usual care on reducing severe agitation in patients with moderate to severe dementia, including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. This single-arm, unblinded, non-randomized trial aims to assess both the impact and safety of ECT plus usual care, as well as the lasting effects of the treatment during a follow-up phase. The study plans to enroll 50 participants and expects about 20% may drop out. Participants will receive ECT treatments using right unilateral electrode placement and ultra-brief pulse width under anesthesia. The initial session determines the seizure threshold, and subsequent treatments are given at approximately six times this threshold, with adjustments made based on seizure quality and treatment effectiveness. After completing at least one ECT session, participants will enter a 12-month naturalistic follow-up phase to observe the treatment's durability. Throughout the study, participants will be monitored with several assessments including the Cohen-Mansfield Agitation Inventory (CMAI) collected over about 13 months, as well as the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC), Neuropsychiatric Inventory Clinician Version (NPI-C), and Pittsburgh Agitation Scale (PAS) during the first month. Safety will be closely observed through physical exams, lab tests, and brain imaging when needed. The entire participation duration covers the initial treatment and extended follow-up to evaluate outcomes and tolerability.
CONDITIONS
Brief Title
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of dementia subtype including Alzheimer's dementia according to NIA-AA criteria, vascular dementia with gradual onset and MRI evidence of microvascular ischemic disease, frontotemporal dementia, or dementia with Lewy Bodies
- Mini Mental Status Exam (MMSE) score of 15 or less
- Cohen-Mansfield Agitation Inventory (CMAI) Nursing Home Version score of 5 or more on at least one item or 4 on two items indicating severe agitation or aggression
- At least one failed medication treatment for behavioral symptoms
- Medically stable for ECT as verified by physical exam, urinalysis, serum chemistries, and brain imaging if needed
- Comprehension of English language
- Authorized legal representative able and willing to provide informed consent
- Age 40 years or older
You will not qualify if you...
- Current diagnosis of delirium confirmed by Confusion Assessment Measure (CAM) or clinical diagnosis
- Vascular dementia due to stroke with abrupt onset, MRI evidence of hemorrhagic or embolic stroke in the past 12 months, or physical/neurologic exam indicating stroke
- Lifetime or current diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder
- Active substance use disorder in the past 6 months
- Treatment with ECT or other neurostimulation therapies like TMS or vagal nerve stimulation within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of at least 1 ECT treatment
Participants receive electroconvulsive therapy (ECT) with anesthesia for severe agitation in dementia, with stimulus settings adjusted during the course of treatment based on response and seizure quality.
Multiple ECT treatment visits as determined by clinical protocol
Duration - Up to 12 months
Participants are followed naturally for up to 12 months to observe the durability of the treatment effect and safety of ECT combined with usual care.
Regular follow-up visits during the 12-month naturalistic follow-up phase
Trial Site Locations
Total: 5 locations
1
Emory Healthcare
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
3
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, United States, 49548
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Northwell Health
Glen Oaks, New York, United States, 11004
Actively Recruiting
Research Team
J
Jefferson Mattingly, BA
S
Sarah Howie, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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