Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) (NCT03926520) | Clinical Trial Compass
RecruitingNot Applicable
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
United States50 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 range40 Years
SexALL
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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).
✓. 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:
What they're measuring
1
CMAI total score
Timeframe: The CMAI will be collected through study completion, about 13 months