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:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT06546995
Eligibility Criteria:
Inclusion Criteria:
Part A
* Healthy participants
* Age 65 to 80 years
* Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit
Part B
* Participants aged 55 to 90 years
* Diagnosis of probable AD or Alzheimer's clinical syndrome according to the National Institute of Aging-Alzheimer's Association criteria at least 12 months prior to screening
* Agitation meets the International Psychogeriatric Association (IPA) consensus definition
* Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) at screening
Exclusion Criteria:
Part A
* Participant is actively suicidal
* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
* Diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures
Part B
* Dementia or memory impairment due to a reason other than AD
* Clinically significant neurologic disorder other than AD
* Have any clinically significant and uncontrolled medical condition
Note: Other protocol defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT06546995
Study Brief:
Protocol Section:
NCT06546995