Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03926520
Eligibility Criteria:
Inclusion Criteria
1. Diagnosis of Dementia, of the following subtypes,
1. Alzheimer's dementia, according to NIA-AA Criteria for dementia
2. 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 examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies
2. Mini Mental Status Exam (MMSE) less than or equal to 15
3. 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).
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 and brain imaging when clinically indicated
6. Comprehension of English language
7. Authorized legal representative able and willing to give informed consent
8. Age 40 and above
Exclusion Criteria:
1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
2. 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
3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
4. Active substance use disorder within past 6 months
5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03926520
Study Brief:
Protocol Section:
NCT03926520