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New treatment option for Alzheimer Dementia
Official title Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
ClinicalTrials.gov ID: NCT03926520
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Diagnosis of Dementia, of the following subtypes,
- Alzheimer's dementia, according to NIA-AA Criteria for dementia
- Vascular dementia based on: i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular...
- 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...
You likely can't join if
- 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:
- History consistent with abrupt onset and step-wise progression of cognitive and functional decline
- MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
- Physical and neurologic examination consistent with current or prior stroke
- Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
See the full eligibility criteria
- Diagnosis of Dementia, of the following subtypes,
- Alzheimer's dementia, according to NIA-AA Criteria for dementia
- Vascular dementia based on: i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological...
- 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...
- 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
- Authorized legal representative able and willing to give informed consent
- Age 40 and above
- 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:
- History consistent with abrupt onset and step-wise progression of cognitive and functional decline
- MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
- Physical and neurologic examination consistent with current or prior stroke
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Belmont, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Glen Oaks, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Belmont, Massachusetts, United States; Grand Rapids, Michigan, United States; Rochester, Minnesota, United States; Glen Oaks, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.