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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03926520
Recruitment Status Not yet recruiting
First Posted April 24, 2019
Last update posted July 31, 2019
This study will explore the efficacy of ECT treatments plus usual care (ECT+UC), relative to a placebo simulated ECT plus usual care (S-ECT+UC) in reducing severe agitation in patients with moderate to severe Alzheimer's Disease. The study will also determine the tolerability/safety outcomes of ECT+UC relative to S-ECT+UC.
This study is a single blind, randomized, Simulated-ECT (S-ECT) controlled trial of electroconvulsive therapy (ECT). The purpose is to determine the efficacy and safety of ECT for severe agitation in moderate to severe stage Alzheimer's Disease (AD), while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. The investigators will study only inpatients with severe agitation and moderate to severe dementia, associated with high care costs and poor quality of life, who typically have already failed prior trials of psychotropic medications. The first aim is to compare the relative efficacy of up to 9 ECT treatments plus usual care (ECT+UC) versus Simulated ECT (S-ECT+UC) in reducing severe agitation in 200 participants with moderate to severe AD. The second aim is to compare the relative tolerability/safety outcomes of ECT+UC versus S-ECT+UC in the same group of participants. The exploratory aim is to understand the stability of agitation reduction (CMAI) and global functioning (ADCS-CGIC) with assessments at 1,3, and 6 months following the acute phase, and then for a fourth visit 12 months after the acute phase. Establishing safety and efficacy of ECT for severe agitation in AD provides an opportunity to decrease long-term care placement, decrease the risk of mortality, decrease caregiver burden, and enhance quality of life for patients and their caregivers.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Diagnosis of Alzheimer's Dementia according to NIA-AA Criteria for dementia 
2. MMSE < 15 3. Cohen-Mansfield Agitation Inventory Short Version (CMAI) score of ≥4 on at least one item, a score of 3 on at least two items, or a score of 2 on at least three items. 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 6. Comprehension of English language 7. Authorized legal representative able and willing to give informed consent 8. Age 55 - 89 years old (inclusive) Exclusion Criteria: 1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis 2. Diagnosis of Non-AD Dementia 3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder 4. Current episode of Major Depressive Disorder (MDD) 5. Active substance use disorder within past 6 months 6. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
Contact: Emily P Kilpatrick, BA 617-855-3136 email@example.com
Contact: Aniqa T Rahman, BA 617-855-3257 firstname.lastname@example.org
Pine Rest Christian Mental Health Services
The Zucker Hillside Hospital
Medical University of South Carolina