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Procedure

ECT for Dementia (ECT-AD Trial)

N/A
Recruiting
Led By George Petrides, MD
Research Sponsored by Brent Forester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Dementia, including Alzheimer's dementia, Vascular dementia, Frontotemporal dementia, Dementia with Lewy Bodies
Age 40 and above
Must not have
Diagnosis of vascular dementia due to stroke
Current diagnosis of co-morbid delirium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the pas will be collected for one month
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two treatments for severe agitation in patients with dementia: electroconvulsive therapy plus usual care (ECT+UC) versus placebo simulated electroconvulsive therapy plus usual care (S-ECT+UC). The study will also compare the safety and tolerability of the two treatments.

Who is the study for?
This trial is for people aged 40+ with moderate to severe dementia, including Alzheimer's, who show severe agitation. They must have tried at least one medication that didn't work and be medically stable for ECT. Those with certain psychiatric disorders, active substance use disorder, or recent neurostimulation therapy can't join.
What is being tested?
The study tests if Electroconvulsive Therapy (ECT) combined with usual care helps reduce severe agitation in dementia patients better than usual care alone. It also assesses the safety of using ECT in these individuals.
What are the potential side effects?
While not specified here, common side effects of ECT may include confusion right after treatment, memory loss (which could be temporary or permanent), physical side effects like headaches, muscle aches or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a form of dementia.
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I am 40 years old or older.
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I have been diagnosed with Dementia with Lewy Bodies.
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I have been diagnosed with Alzheimer's dementia.
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I have been diagnosed with frontotemporal dementia.
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I have never had a stroke, confirmed by physical and neurological exams.
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I have been diagnosed with a specific type of dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with vascular dementia caused by a stroke.
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I am currently diagnosed with delirium alongside other conditions.
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I haven't had ECT or similar therapies in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the adcs-cgic will be collected for one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and the adcs-cgic will be collected for one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CMAI total score
Secondary study objectives
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
Neuropsychiatric Inventory, Clinician Version (NPI-C)
Pittsburgh Agitation Scale (PAS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ECT+UC groupExperimental Treatment1 Intervention
ECT with Usual Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroconvulsive Therapy (ECT)
2000
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

Brent ForesterLead Sponsor
Mayo ClinicOTHER
3,333 Previous Clinical Trials
3,060,122 Total Patients Enrolled
3 Trials studying Psychomotor Agitation
44 Patients Enrolled for Psychomotor Agitation
Pine Rest Christian Mental Health ServicesOTHER
5 Previous Clinical Trials
472 Total Patients Enrolled
1 Trials studying Psychomotor Agitation
23 Patients Enrolled for Psychomotor Agitation

Media Library

Electroconvulsive Therapy (ECT) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03926520 — N/A
Psychomotor Agitation Research Study Groups: ECT+UC group
Psychomotor Agitation Clinical Trial 2023: Electroconvulsive Therapy (ECT) Highlights & Side Effects. Trial Name: NCT03926520 — N/A
Electroconvulsive Therapy (ECT) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03926520 — N/A
~6 spots leftby May 2025
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