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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03325556
Eligibility Criteria:
Inclusion Criteria:
1. Meets criteria for All-cause Dementia according to NIA-AA guidelines
2. Meets clinical criteria for one of the following disorders: Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's disease, Frontotemporal degeneration spectrum disorders, Vascular dementia
3. Has an MMSE score ≥6 and ≤24
4. Has had psychotic symptoms for at least 2 months
5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable
6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study
Exclusion Criteria:
1. Has psychotic symptoms that are primarily attributable to a condition other than dementia
2. Has had a recent major depressive episode
3. Has experienced suicidal ideation or behavior within 3 months prior to study enrollment
4. Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition
5. Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke
6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope
7. Has any of the following: greater than New York Heart Association (NYHA) Class 2 congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator
8. Had a myocardial infarction within the last 6 months
9. Has a known personal or family history or symptoms of long QT syndrome
10. Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures
11. Requires treatment with a medication or other substance that is prohibited by the protocol
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT03325556
Study Brief:
Protocol Section:
NCT03325556