ECT for Dementia

(ECT-AD Trial)

Recruiting at 4 trial locations

Overseen By Sarah Howie, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brent Forester

Disqualifiers: Delirium, Stroke, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

50 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 4 6 7}

Who Is on the Research Team?

Brent P Forester, MD

Principal Investigator

Mclean Hospital

George Petrides, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: ECT+UC group Experimental Treatment 1 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)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECT for major depression and mania with advanced dementia. Weintraub, D., Lippmann, SB.[2019]

Electroconvulsive therapy (ECT) has been found to be an effective treatment for depression in patients with dementia, resulting in a significant average reduction of 12.28 points on the Montgomery-Asberg Depression Rating Scale (MADRS).

Despite some patients experiencing delirium, there was also a notable improvement in cognitive function, as indicated by a mean increase of 1.62 points on the Mini-Mental State Examination (MMSE) after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits and risks of ECT for patients with primary dementia who also suffer from depression. Rao, V., Lyketsos, CG.[2022]

A novel regimen of alternating acute and maintenance electroconvulsive therapy (M-ECT) was successfully used to manage behavioral and psychological symptoms of dementia (BPSD) in a 64-year-old man, highlighting its potential effectiveness in improving quality of life.

This case study suggests that M-ECT can help sustain the benefits of acute ECT, particularly in managing aggression in dementia patients, and raises awareness of the challenges associated with stopping ECT treatment abruptly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of maintenance electroconvulsive therapy for sustaining resolution of severe aggression in a major neurocognitive disorder. Selvadurai, MI., Waxman, R., Ghaffar, O., et al.[2019]

Electroconvulsive therapy (ECT) may be an effective treatment for severe agitation and aggression in dementia patients, with 88% of the 122 patients studied showing clinically significant improvement, often early in treatment.

Most adverse effects reported were mild and transient, suggesting that ECT could be a safe option for patients who do not respond to other treatments, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy for Agitation and Aggression in Dementia: A Systematic Review. van den Berg, JF., Kruithof, HC., Kok, RM., et al.[2019]

Electroconvulsive therapy (ECT) was successfully used to treat severe agitation in a 57-year-old woman with early-onset Alzheimer's disease, resulting in significant clinical improvement after eight sessions without cognitive decline.

This case suggests that ECT may be a safe and effective alternative for managing agitation in Alzheimer's patients who do not respond to traditional antipsychotic medications, warranting further investigation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe agitation in severe early-onset Alzheimer's disease resolves with ECT. Aksay, SS., Hausner, L., Frölich, L., et al.[2020]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

Electroconvusive therapy in dementia. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Electroconvulsive Therapy on Functional Outcomes Among Medicare Patients With Comorbid Depression and Dementia: A Nationwide 1-Year Follow-Up Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

ECT for major depression and mania with advanced dementia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The benefits and risks of ECT for patients with primary dementia who also suffer from depression. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of maintenance electroconvulsive therapy for sustaining resolution of severe aggression in a major neurocognitive disorder. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Electroconvulsive Therapy for Agitation and Aggression in Dementia: A Systematic Review. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Severe agitation in severe early-onset Alzheimer's disease resolves with ECT. [2020]