50 Participants Needed

ECT for Dementia

(ECT-AD Trial)

Recruiting at 4 trial locations
AT
HL
JM
MD
SH
Overseen BySarah Howie, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brent Forester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves ECT plus usual care, it might be possible to continue your current treatments. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Electroconvulsive Therapy (ECT) for dementia?

Research suggests that Electroconvulsive Therapy (ECT) can be effective and safe for improving symptoms in patients with dementia, especially when they also have depression or severe behavioral issues. Some studies have shown that ECT helps with depression and aggression in dementia patients, although there are concerns about its effects on memory and thinking skills.12345

Is Electroconvulsive Therapy (ECT) safe for treating dementia-related symptoms?

Research suggests that ECT is generally safe for treating behavioral and psychological symptoms in dementia, such as aggression and agitation, with some studies showing it is well-tolerated without worsening cognitive function.12567

How is electroconvulsive therapy (ECT) different from other treatments for dementia?

Electroconvulsive therapy (ECT) is unique because it uses electrical currents to induce controlled seizures, which can improve symptoms of depression and behavioral issues in dementia patients, especially when other treatments are ineffective. Unlike medications, ECT can be effective for severe cases and offers a different approach by directly affecting brain activity.12345

What is the purpose of this trial?

This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.

Research Team

Brent Forester MD - TECHNOLOGY & AGING ...

Brent P Forester, MD

Principal Investigator

Mclean Hospital

GP

George Petrides, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Inclusion Criteria

Authorized legal representative able and willing to give informed consent
I have never had a stroke, confirmed by physical and neurological exams.
I have been diagnosed with a form of dementia.
See 12 more

Exclusion Criteria

I have been diagnosed with vascular dementia caused by a stroke.
I am currently diagnosed with delirium alongside other conditions.
I haven't had ECT or similar therapies in the last 3 months.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Electroconvulsive Therapy (ECT) plus usual care for severe agitation in dementia

1 month
Weekly ECT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Electroconvulsive Therapy (ECT)
  • Simulated Electroconvulsive Therapy (S-ECT)
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ECT+UC groupExperimental Treatment1 Intervention
ECT with Usual Care

Electroconvulsive Therapy (ECT) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Electroconvulsive Therapy for:
  • Severe depression
  • Bipolar disorder
  • Schizophrenia
  • Catatonia
  • Agitation in dementia (off-label)
🇪🇺
Approved in European Union as Electroconvulsive Therapy for:
  • Severe depression
  • Bipolar disorder
  • Schizophrenia
  • Catatonia
  • Agitation in dementia (off-label)
🇨🇦
Approved in Canada as Electroconvulsive Therapy for:
  • Severe depression
  • Bipolar disorder
  • Schizophrenia
  • Catatonia
  • Agitation in dementia (off-label)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brent Forester

Lead Sponsor

Trials
1
Recruited
50+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Pine Rest Christian Mental Health Services

Collaborator

Trials
6
Recruited
520+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

The Zucker Hillside Hospital

Collaborator

Trials
14
Recruited
1,200+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Findings from Research

Electroconvulsive therapy (ECT) is considered effective and safe for improving functional outcomes in elderly patients with both affective disorders and dementia syndromes.
The study highlights the clinical challenge of differentiating between depressive episodes and early signs of dementia, suggesting a potential overlap in their causes.
Electroconvusive therapy in dementia.Rodríguez-Sosa, JT., Suárez-Lovelle, A., Navarrete-Betancort, E., et al.[2013]
Electroconvulsive therapy (ECT) was associated with a slower rate of functional decline in older adults with comorbid depression and dementia, particularly in activities like bathing and transferring, based on a study of 147 ECT-treated patients compared to 415 controls.
While ECT did not significantly improve cognition or ambulation, it did not worsen functional outcomes, suggesting it may be a safe option for managing behavioral and psychological symptoms of dementia.
Effects of Electroconvulsive Therapy on Functional Outcomes Among Medicare Patients With Comorbid Depression and Dementia: A Nationwide 1-Year Follow-Up Study.Wilkinson, ST., Sint, K., Forester, BP., et al.[2023]
Electroconvulsive therapy (ECT) was successfully used to treat two patients with advanced dementia and severe affective disorders, demonstrating its efficacy in managing depression and mania in this challenging population.
The treatment was administered without significant adverse effects, suggesting that ECT can be a safe option for patients with moderate to severe dementia.
ECT for major depression and mania with advanced dementia.Weintraub, D., Lippmann, SB.[2019]

References

Electroconvusive therapy in dementia. [2013]
Effects of Electroconvulsive Therapy on Functional Outcomes Among Medicare Patients With Comorbid Depression and Dementia: A Nationwide 1-Year Follow-Up Study. [2023]
ECT for major depression and mania with advanced dementia. [2019]
The benefits and risks of ECT for patients with primary dementia who also suffer from depression. [2022]
Efficacy and safety of maintenance electroconvulsive therapy for sustaining resolution of severe aggression in a major neurocognitive disorder. [2019]
Electroconvulsive Therapy for Agitation and Aggression in Dementia: A Systematic Review. [2019]
Severe agitation in severe early-onset Alzheimer's disease resolves with ECT. [2020]
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