Electroconvulsive Therapy (ECT) for Agitation in Alzheimer's Dementia (AD)
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|ClinicalTrials.gov Identifier: NCT03926520|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Dementia Agitation,Psychomotor||Device: Electroconvulsive Therapy (ECT) Other: Simulated Electroconvulsive Therapy (S-ECT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Trial of Electroconvulsive Therapy Plus Usual Care Versus Simulated-ECT Plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia|
|Estimated Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
|Experimental: ECT+UC group||
Device: 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.
|Sham Comparator: S-ECT+UC group||
Other: Simulated Electroconvulsive Therapy (S-ECT)
The participant is brought to the ECT suite for the length a session would normally take (approximately 2 hours). While in the ECT suite, conducting gel will be placed on the scalp of the S-ECT subjects to parallel the ECT procedures in the ECT active group. A Band-Aid will also be placed on the arm of the S-ECT subjects to parallel the Band-Aid placed at the IV site for the ECT active group. Participants will not be administered anesthesia.
- 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 than S-ECT. 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.
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC) [ Time Frame: The ADCS-CGIC will be collected through study completion, about 13 months ]The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.
- Neuropsychiatric Inventory (NPI) [ Time Frame: The NPI will be collected for one month ]The NPI is composed of several domains in which subscores on frequency and severity will be derived. The higher the frequency and/or severity within each domain, the worse the condition of the patient.
- Pittsburgh Agitation Scale (PAS) [ Time Frame: The PAS will be collected for one month ]The PAS assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926520
|Contact: Emily P Kilpatrick, BAemail@example.com|
|Contact: Aniqa T Rahman, BAfirstname.lastname@example.org|