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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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.
Emory Healthcare
Atlanta, Georgia, United States
McLean Hospital
Belmont, Massachusetts, United States
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: The CMAI will be collected through study completion, about 13 months
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.
Time frame: 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.
Time frame: 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.
Time frame: The PAS will be collected for one month
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Northwell Health
Glen Oaks, New York, United States