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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07399418
Eligibility Criteria:
Inclusion Criteria (patients):
* Age ≥ 50 years.
* Presence of a primary caregiver, i.e., a person who provides regular care and who can actively participate in the study.
* Understanding of the research objectives and ability to provide informed consent.
Inclusion Criteria (caregivers):
* Be the primary caregiver, providing care for at least six months.
* Age ≥ 18 years, to ensure the ability to understand and actively participate in the study.
* Understanding of the research objectives and ability to provide informed consent.
Exclusion Criteria (patients):
* Age under 50.
* History of previous or concomitant neurological disorders (e.g., severe cerebrovascular accidents, brain tumors, traumatic injuries affecting cognitive functions) and neurodegenerative disorders.
* History of major psychiatric disorders (e.g., schizophrenia, severe bipolar disorder, untreated major depression), alcohol or substance abuse.
* Medical conditions that may interfere with cognitive function (e.g., advanced renal or hepatic failure, severe respiratory disorders, untreated hypothyroidism, B12 deficiency).
* Decompensated systemic diseases with clinical instability and significant organ failure.
* Marked sensory limitations (hearing or vision) and/or language difficulties.
* Participation in other experimental studies involving previous or current involvement in clinical trials of anti-amyloid drugs or experimental drug treatments for AD in the previous 6 months.
Exclusion Criteria (caregivers):
* Presence of severe active psychiatric disorders (e.g., untreated major depression, psychotic disorder, or schizophrenia).
* Difficulty participating in interviews and assessments due to language barriers, cognitive deficits, or other personal limitations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT07399418
Study Brief:
Protocol Section:
NCT07399418