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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06604520
Eligibility Criteria:
FTD Patients
Inclusion Criteria:
1. Male or Female
2. Age 45 and above
3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
5. A global Clinical Dementia Rating (CDR®) plus National Alzheimer's Coordinating Center (NACC) Frontotemporal lobar degeneration (FTLD) Behavior and Language Domains global score (CDR® plus NACC FTLD) less than or equal to one
6. Patients must be medically stable
7. Vortioxetine treatment is clinically indicated
8. Competent to provide informed consent
Exclusion Criteria:
1. No history of drug or alcohol dependence within six months prior to study entry
2. Negative toxicology screening for drugs of abuse
3. Subject must not be pregnant or nursing
4. No contraindications to Vortioxetine treatment
5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)
Healthy Controls
Inclusion Criteria:
1. Male or Female
2. Age 45 and above
3. Subjects must be medically stable
4. Free of psychotropic medications
5. Competent to provide informed consent
Exclusion Criteria:
1. No current or past history of neurological or psychiatric illness or substance abuse
2. Subject must not be pregnant or nursing
3. Negative toxicology screening for drugs of abuse
4. No contraindications for MR scanning (e.g. metal implanted in the body)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT06604520
Study Brief:
Protocol Section:
NCT06604520