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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT07234851
Eligibility Criteria:
Inclusion criteria for psychiatric disorders:
* Age group: Midlife brain donors (age-at-death\>40).
* Sex distribution: % Female in schizophrenia (23%), major depressive disorder and controls (40%), bipolar disorder and controls (55%). These percentages match those typically found in these disorders.
* Antemortem diagnosis of schizophrenia (paranoid-subtype diagnoses only to minimise the impact of potential confounding factors on the results and ensure homogeneity across schizophrenia subjects), major depression or bipolar disorder. Diagnoses are confirrmed antemortem by a psychiatrist using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria, as recorded in the deceased individuals' medical records.
Exclusion criteria for psychiatric disorders:
For schizophrenia, cases displaying additional neurological or psychiatric conditions, such as histories of substance use disorder will be excluded. Postmortem delay \>24h (to minimise perimortem confounding variables potentially affecting tissue quality.
Inclusion criteria for Neurodegenerative diseases:
* Age group: Latelife brain donors (age-at-death\>50).
* Sex distribution: Alzheimer's disease (60%), frontotemporal dementia (65%). These percentages match those typically found in these diseases.
* Neuropathological confirmation of Alzheimer's disease or frontotemporal lobar degeneration (C9orf72 repeat expansion carrier)Alzheimer's disease
Exclusion criteria for Neurodegenerative diseases:
Postmortem delay \>24h (to minimise perimortem confounding variables potentially affecting tissue quality.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07234851
Study Brief:
Protocol Section:
NCT07234851