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

Phase 2RecruitingNCT06604520

Johns Hopkins University50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fronto-temporal Dementia Fronto-temporal Lobar Dementia

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)

Cerebral glucose uptake measured through 18F FDG positron emission tomography

Time frame: Baseline, 12 weeks

Secondary Outcomes

Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).

The HDRS is a widely used clinician-administered depression assessment tool designed to measure the severity of depression in individuals. It consists of 17 items rated on a 3 or 5 point scale with total scores ranging from 0 to 52. A higher score indicates more severe symptoms of depression.