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Procedure

ECT for Dementia (ECT-AD Trial)

N/A
Recruiting
Led By Brent P Forester, MD, MSc
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the pas will be collected for one month
Awards & highlights

ECT-AD Trial 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.Check my eligibility
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.See study design
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.

ECT-AD Trial 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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My health is stable enough for ECT, confirmed by tests and possibly brain scans.
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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.
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I have tried at least one medication for behavioral symptoms that didn't work.

ECT-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the cmai will be collected through study completion, about 13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and the cmai will be collected through study completion, about 13 months for reporting.

Treatment Details

Study Objectives

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

ECT-AD Trial Design

1Treatment groups
Experimental Treatment
Group I: ECT+UC groupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroconvulsive Therapy (ECT)
2000
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

Brent ForesterLead Sponsor
Mayo ClinicOTHER
3,191 Previous Clinical Trials
3,758,461 Total Patients Enrolled
3 Trials studying Psychomotor Agitation
98 Patients Enrolled for Psychomotor Agitation
Pine Rest Christian Mental Health ServicesOTHER
4 Previous Clinical Trials
442 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who fulfills the criteria to join this trial?

"This trial aims to enroll 200 individuals aged 55-89 suffering from akathisia. To qualify, a patient must have been diagnosed with one of the following dementias according to NIA-AA Criteria: Alzheimer's dementia, Frontotemporal dementia, or Dementia with Lewy Bodies; show an MMSE score ≤ 15 as well as evidence of microvascular ischemic disease and clinical decline on MRI scans; and demonstrate at least 5 points in Cohen-Mansfield Agitation Inventory Short Version aggression/dangerous items (1-11, 14, 15, 22-24) that may include physical"

Answered by AI

How many participants are enrolling in the experiment?

"This medical experiment necessitates that 200 individuals, who meet the established admittance criteria, partake in this trial from sites such as Mayo Clinic located in Rochester, Minnesota and Pine Rest Christian Mental health Services based out of Grand Rapids, Michigan."

Answered by AI

Is the inclusion criterion for this research study restricted to individuals above a certain age?

"The age range specified by the parameters of this trial is 55 to 89 years old."

Answered by AI

Is this experimental procedure available to participants at the present moment?

"Affirmative. The information made accessible on clinicaltrials.gov indicates that this research project, which was initially advertised in January 2021 is currently recruiting subjects. About 200 people are needed from 5 distinct medical centres to complete the trial."

Answered by AI

Are there any medical facilities in North America currently executing this experiment?

"Patients are being recruited to the trial in various regions, including Mayo Clinic Rochester, Pine Rest Christian Mental health Services Grand Rapids and McLean Hospital Belmont. Additionally, there are 5 other recruiting sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Pine Rest Christian Mental Health Services
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~1 spots leftby May 2024