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 trial tests the effectiveness of electroconvulsive therapy (ECT) combined with usual care in reducing severe agitation in individuals with moderate to severe dementia, including Alzheimer's and other types. Researchers aim to assess the safety and tolerability of this treatment for patients. Suitable candidates typically have a diagnosed type of dementia, frequently experience severe agitation, and have not found success with medication. As an unphased trial, this study provides a unique opportunity to enhance understanding and potentially improve treatment options for dementia-related agitation.

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 prior data suggests that Electroconvulsive Therapy (ECT) is safe for patients with dementia?

Research has shown that Electroconvulsive Therapy (ECT) is generally safe for individuals with mental health conditions. It does not increase the risk of developing dementia in patients with schizophrenia, bipolar disorder, or major depression. This suggests it might also be safe for those already diagnosed with dementia.

Studies indicate that ECT can quickly and effectively alleviate severe symptoms of depression and restlessness. Restlessness affects nearly 60% of people with dementia, and ECT could help reduce this issue, easing the burden on caregivers.

Overall, ECT is well-tolerated and does not raise the risk of serious outcomes like suicide or death, according to consistent findings. While every treatment carries potential risks, evidence supports ECT as a generally safe option for addressing severe restlessness in dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for dementia, which often involve medications like cholinesterase inhibitors or memantine, electroconvulsive therapy (ECT) offers a unique approach. ECT is known for its rapid impact on severe depression, but researchers are exploring its potential to improve mood and cognitive function in dementia patients. This treatment could provide faster symptom relief and be particularly beneficial for individuals who don't respond well to traditional medications.

What evidence suggests that Electroconvulsive Therapy (ECT) might be an effective treatment for severe agitation in dementia?

Research has shown that Electroconvulsive Therapy (ECT), which participants in this trial may receive, can quickly and significantly improve severe mental health symptoms, such as depression and agitation. Agitation affects about 60% of people with dementia, so ECT might be a helpful treatment for them. Studies have found ECT to be a safe and highly effective way to treat severe agitation. Recent evidence indicates that most people who undergo ECT report their memory remains the same or improves. While ECT is primarily used for depression, its ability to reduce agitation could help people with dementia feel less distressed. ^{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 am currently diagnosed with delirium alongside other conditions.

I have been diagnosed with vascular dementia caused by a stroke.

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) 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 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]

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) 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6138057/

Electroconvulsive Therapy and Risk of Dementia—A ... This study supports that ECT was not associated with the increased risk of dementia in patients with schizophrenia, bipolar disorder, and major depressive ...

2. mayoclinic.org mayoclinic.org/tests-procedures/electroconvulsive-therapy/about/pac-20393894

Electroconvulsive therapy (ECT) This procedure can greatly and rapidly improve severe symptoms of depression, mania, catatonia or other mental health conditions.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20508007

Electroconvulsive Therapy in Severe Agitation ... It is a safe and highly effective treatment for depression. Agitation is common in nearly 60% of patients with dementia, increases caretaker burden, ...

4. rcpsych.ac.uk rcpsych.ac.uk/news-and-features/latest-news/detail/2023/12/19/new-data-shows-more-than-a-thousand-people-benefit-from---life-saving-electroconvulsive-therapy--majority-of-which-are-women

New data shows more than a thousand people benefit from ... Memory loss is a recognised side effect of ECT; however, nine out of ten patients said their memory had improved or stayed the same following ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22002054

Effectiveness of electroconvulsive therapy in patients ... ECT is equally, if not superiorly, effective in patients lacking DMC-T compared to patients with DMC-T. ECT can potentially enhance patients' autonomy.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546016/

Electroconvulsive Therapy for the Treatment of the ... - NCBI Data from three reviews suggested that patients relapsed between one week and 5 years of being treated with ECT. Coupled with the mixed and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S245190222400380X

Effects of Electroconvulsive Therapy on Brain Structure Moreover, studies that have examined the risk of dementia, suicide, and other mortality after ECT have consistently concluded that ECT is not associated with ...