Electroconvulsive Therapy in Severe Agitation in Alzheimer's Dementia

Overview

About this study

McLean hospital,  Mayo Clinic,  Emory University, LIJ/Northwell, and Pine Rest Mental Health are conducting a research study using Electroconvulsive therapy (ECT)  to treat agitation in dementia. ECT is a treatment done under general anesthesia, in which brief electric currents are passed through the brain to trigger a brief seizure. It is a safe and highly effective treatment for depression.

 

Agitation is common in nearly 60% of patients with dementia, increases caretaker burden, creates safety risk for individuals with dementia and others and increases risk for hospitalization and nursing home placement.

 

While ECT is not widely used for the treatment of agitation in patients with dementia, several publications have demonstrated its ability to help for these problematic behaviors that can accompany dementia. We propose to address this critical need for a new intervention to treat severe agitation in dementia by conducting a single blind, randomized controlled trial of electroconvulsive therapy (ECT).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of Alzheimer’s Dementia according to NIA-AA Criteria for dementia.
  • MMSE ≤ 15.
  • Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of >5 on at least one item of aggression or a physical nonaggressive item 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, intentional falling, screaming, making verbal sexual advances, and cursing or verbal aggression (items 1-11, 14, 15, 22-24).
  • At least three failed pharmacological interventions from different drug classes (including antidepressants, antipsychotics, anticonvulsants, prazosin, and cannabinoids) at therapeutic doses (to be determined by clinical judgment) and duration of at least two weeks each to manage behavioral symptoms. These interventions may also include medications discontinued after 1 week due to tolerability concerns. Furthermore, medication trials that occur prior to admission to the hospital may count towards the three failed trials. The trials can be inpatient and/or outpatient. These trials can also be concurrent, such as using two medications from different classes for at least one week  at the same time (i.e., polypharmacy).
  • Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries.
  • Comprehension of English language.
  • Authorized legal representative able and willing to give informed consent.
  • Age 55 - 89 years old (inclusive).

Exclusion Criteria:

  • Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Method (CAM) and by clinical diagnosis.
  • Diagnosis of Non-AD Dementia.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Maria Lapid, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Monica Walton B.S.

(507) 422-0689

Walton.Monica@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20508007

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