Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia

Johns Hopkins University

Status and phase: Enrolling; Phase 2

Conditions: Frontotemporal Degeneration; Fronto-temporal Dementia; Frontotemporal Dementia; Fronto-temporal Lobar Dementia; Frontotemporal Dementia, Behavioral Variant; Frontotemporal Dementia (FTD)

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06604520

1K23AG088248 (U.S. NIH Grant/Contract)

IRB00403796

Details and patient eligibility

About

The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The main questions this study aims to answer are:

1. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD?
2. Do mood symptoms and cognition improve following treatment with vortioxetine?

Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment.

Participants will:

• Undergo a screening visit that involves clinical assessments and laboratory tests
• Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine
• Undergo memory and problem-solving tests before starting treatment with vortioxetine
• Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist
• Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine

Enrollment: 50 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Patient Treatment Arm (Vortioxetine)

Experimental group

Description:

Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.

Treatment:

Drug: Vortioxetine