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

NCT ID: NCT06604520

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2029-09-01

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Treatment Arm (Vortioxetine)

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine

Interventions

Vortioxetine

Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine

Intervention Type: DRUG

Other Intervention Names

Trintellix

Eligibility Criteria

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

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 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

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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Lundbeck LLC

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Morrow, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher B Morrow, MD

Role: CONTACT

cmorrow3@jhmi.edu

410-502-6509

Facility Contacts

Christopher B Morrow, MD

Role: primary

cmorrow3@jhmi.edu

410-502-6509

Other Identifiers

1K23AG088248

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00403796

Identifier Type: -

Identifier Source: org_study_id