Using Electroconvulsive Therapy to Reduce Agitation in Dementia
Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia
This study is testing if Electroconvulsive Therapy can help reduce severe agitation in people with moderate to severe dementia, including Alzheimer's, while they receive regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT03926520 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Electroconvulsive Therapy (ECT) combined with usual care on severe agitation in patients with moderate to severe dementia, including Alzheimer's Disease and other dementia subtypes. It is a single-arm, unblinded, non-randomized trial aiming to enroll 50 participants, assessing both the efficacy and safety of ECT treatments. Participants will receive at least one ECT treatment followed by a 12-month naturalistic follow-up phase to evaluate the durability of treatment effects.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with moderate to severe dementia, such as Alzheimer's, Vascular dementia, Frontotemporal dementia, or Dementia with Lewy Bodies, who exhibit severe agitation.
Not a fit: Patients with mild dementia or those without significant agitation symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce severe agitation in dementia patients, improving their quality of life and care.
How similar studies have performed: While ECT has been used for various psychiatric conditions, this specific application for severe agitation in dementia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Diagnosis of Dementia, of the following subtypes, 1. Alzheimer's dementia, according to NIA-AA Criteria for dementia 2. Vascular dementia based on: i. 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 2. Mini Mental Status Exam (MMSE) less than or equal to 15 3. 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). 4. At least one failed pharmacological intervention to manage behavioral symptoms 5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated 6. Comprehension of English language 7. Authorized legal representative able and willing to give informed consent 8. Age 40 and above Exclusion Criteria: 1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis 2. 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 3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder 4. Active substance use disorder within past 6 months 5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
Where this trial is running
Atlanta, Georgia and 4 other locations
- Emory Healthcare — Atlanta, Georgia, United States (Recruiting)
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
- Pine Rest Christian Mental Health Services — Grand Rapids, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Northwell Health — Glen Oaks, New York, United States (Recruiting)
Study contacts
- Principal investigator: Brent P Forester, MD, MSc — Mclean Hospital
- Study coordinator: Jefferson Mattingly, BA
- Email: jmattingly@mclean.harvard.edu
- Phone: 617-855-3168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.