Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) (NCT03926520) | Clinical Trial Compass
CompletedNot Applicable
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
United States41 participantsStarted 2021-01-28
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of Dementia, of the following subtypes,
. Alzheimer's dementia, according to NIA-AA Criteria for dementia
. Vascular dementia based on:
. Mini Mental Status Exam (MMSE) less than or equal to 15
. Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, or intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used electroconvulsive therapy — which most people associate with treating severe depression — to manage agitation in Alzheimer's dementia, so can you explain why ECT would even be considered for behavioral symptoms like this, and how it's thought to work in that context?
2The trial measured agitation using something called the CMAI total score — can you help me understand what that scale actually captures, and whether the changes seen in this completed study were meaningful enough in real life to make a difference for someone living with dementia?
3Since this trial is listed as Phase NA, which often means it's a very early or exploratory study, what does that tell us about how much we know so far about the safety and effectiveness of ECT for dementia-related agitation compared to other options?
4ECT typically requires anesthesia and repeated sessions, which can be demanding — given the physical and cognitive vulnerabilities that come with Alzheimer's, what are the specific risks my loved one's care team would need to weigh before considering this kind of treatment?
5Are there standard medications or non-drug behavioral approaches for agitation in Alzheimer's dementia that we haven't fully tried yet, and would it make sense to explore those before even discussing whether something like ECT could be relevant for our situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CMAI total score
Timeframe: The CMAI will be collected through study completion, about 13 months
. At least one failed pharmacological intervention to manage behavioral symptoms
. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated
. Comprehension of English language
Exclusion criteria
. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
. Diagnosis of vascular dementia due to stroke, based on:
. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
. Active substance use disorder within past 6 months
. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months