Alzheimer DementiaECT-ADNCT03926520
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
A study testing Electroconvulsive Therapy (ECT) in people with Alzheimer Dementia and Agitation,Psychomotor, run by Brent Forester at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Dementia, Agitation,Psychomotor
- What is being tested?
- Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jan 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Dementia, of the following subtypes,
- Alzheimer's dementia, according to NIA-AA Criteria for dementia
- Vascular dementia based on:
- History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies
- 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).
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- 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
- Authorized legal representative able and willing to give informed consent
- Age 40 and above
Who cannot join
- 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:
- History consistent with abrupt onset and step-wise progression of cognitive and functional decline
- MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
- Physical and neurologic examination consistent with current or prior stroke
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory Healthcare
Atlanta, Georgia, 30308
McLean Hospital
Belmont, Massachusetts, 02478
Northwell Health
Glen Oaks, New York, 11004
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
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.
Read the detailed description
This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.
- Conditions
- Alzheimer Dementia, Agitation,Psychomotor
- Being tested
- Electroconvulsive Therapy (ECT)
- Keywords
- ECT, Agitation, Alzheimer's, Dementia
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT)Device
Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| ECT+UC group | Experimental | ECT with Usual Care Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMAI total score
The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.
Measured: The CMAI will be collected through study completion, about 13 months
Secondary outcomes (3)
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.
Measured: The ADCS-CGIC will be collected for one month
Neuropsychiatric Inventory, Clinician Version (NPI-C)
The NPI-C is an improved version of the NPI composed of several domains of which we will use Agitation and Aggression, as well as their sum. The higher the frequency and/or severity within each domain, the worse the condition of the patient.
Measured: The NPI-C will be collected for one month
Pittsburgh Agitation Scale (PAS)
The PAS assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.
Measured: The PAS will be collected for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start28 Jan 2021
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brent Forester
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Pine Rest Christian Mental Health Services, Emory University, The Zucker Hillside Hospital, Medical University of South Carolina
- Responsible party
- Sponsor-investigator, Brent Forester, Mclean Hospital
- Investigators
- Brent P Forester, MD, MSc, Principal investigator, Mclean HospitalGeorge Petrides, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926520
- Sponsor's protocol ID
- 2020P002276
- Acronym
- ECT-AD
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2019
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
- ClinicalTrials.gov ID
- NCT03926520
- Acronym / sponsor ID
- ECT-AD / 2020P002276
- Conditions
- Alzheimer Dementia, Agitation,Psychomotor
- Keywords
- ECT, Agitation, Alzheimer's, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brent ForesterUniversity, hospital or other
- Collaborators
- Mayo Clinic, Pine Rest Christian Mental Health Services, Emory University, The Zucker Hillside Hospital, Medical University of South Carolina
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a single-arm, unblinded, non-randomized trial to determine the effect and safety of ECT for severe agitation in moderate to severe stage dementia, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. We plan to enroll 50 participants with an estimated dropout rate of 20%. We expect 50 participants to complete at least 1 ECT treatment before moving into the 12-month naturalistic follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT+UC group | Experimental | Device: Electroconvulsive Therapy (ECT)ECT with Usual Care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of Dementia, of the following subtypes,
- 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).
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive Therapy (ECT)Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia. | Device | ECT+UC group |
Primary outcome
CMAI total score
Time frame: The CMAI will be collected through study completion, about 13 months
The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.
3 secondary outcomes
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC)
Time frame: The ADCS-CGIC will be collected for one month
Neuropsychiatric Inventory, Clinician Version (NPI-C)
Time frame: The NPI-C will be collected for one month
Pittsburgh Agitation Scale (PAS)
Time frame: The PAS will be collected for one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent P Forester, MD, MSc principal investigator
Mclean Hospital
George Petrides, MD principal investigator
Northwell Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy (ECT) in people with Alzheimer Dementia and Agitation,Psychomotor, run by Brent Forester at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMAI total score (time frame: The CMAI will be collected through study completion, about 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.