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

Last updated: March 27, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2

Condition

Memory Loss

Frontotemporal Dementia

Dementia

Treatment

Vortioxetine

Clinical Study ID

NCT06604520
IRB00403796
1K23AG088248
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

FTD Patients

Inclusion Criteria:

  1. Male or Female

  2. Age 45 and above

  3. Diagnosis of possible or probable bvFTD based on international consensus criteriafor behavioral variant FTD (FTDC)

  4. The presence of at least one of the following affective symptoms on the 12-itemNeuropsychiatric Inventory: depression, anxiety, irritability, or agitation

  5. A global Clinical Dementia Rating (CDR®) plus National Alzheimer's CoordinatingCenter (NACC) Frontotemporal lobar degeneration (FTLD) Behavior and Language Domainsglobal 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

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 inthe 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)

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Vortioxetine
Phase: 2
Study Start date:
March 20, 2025
Estimated Completion Date:
September 01, 2029

Connect with a study center

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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