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NCT Number: NCT06604520

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

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

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Key information

Conditions

Fronto-Temporal Dementia Brain Diseases Central Nervous System Diseases Dementia Fronto-temporal Lobar Dementia Frontotemporal Degeneration Frontotemporal Dementia Frontotemporal Dementia (FTD) Frontotemporal Dementia, Behavioral Variant Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pick Disease of the Brain Proteostasis Deficiencies TDP-43 Proteinopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Christopher B Morrow, MD

CONTACT

[email protected]

410-502-6509

Christopher B Morrow, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

FTD Patients

Inclusion criteria

  • Male or Female
  • Age 45 and above
  • Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
  • The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
  • 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
  • Patients must be medically stable
  • Vortioxetine treatment is clinically indicated
  • Competent to provide informed consent

Exclusion criteria

  • No history of drug or alcohol dependence within six months prior to study entry
  • Negative toxicology screening for drugs of abuse
  • Subject must not be pregnant or nursing
  • No contraindications to Vortioxetine treatment
  • No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)

Healthy Controls

Inclusion criteria

  • Male or Female
  • Age 45 and above
  • Subjects must be medically stable
  • Free of psychotropic medications
  • Competent to provide informed consent

Exclusion criteria

  • No current or past history of neurological or psychiatric illness or substance abuse
  • Subject must not be pregnant or nursing
  • Negative toxicology screening for drugs of abuse
  • No contraindications for MR scanning (e.g. metal implanted in the body)

Treatment and study plan

Vortioxetine

Drug

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

Other names: Trintellix

Primary outcomes

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

    Time frame: Baseline, 12 weeks

    Cerebral glucose uptake measured through 18F FDG positron emission tomography

Secondary outcomes

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

    Time frame: Baseline, 12 weeks

    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.

Other outcomes

  1. Change in performance on the Trail Making Test (TST).

    Time frame: Baseline, 12 weeks

    The TMT is a widely used neuropsychological test that assesses an individuals cognitive abilities including executive function, attention, processing speed, and mental flexibility. It is divided into two parts: Trail Making Test A and Trail Making Test B. The Trail Making Test A primarily assesses visual attention and processing speed. Time taken to complete the task is recorded, with faster times indicating better cognitive performance. The Trail Making Test B primarily assesses cognitive flexibility, executive functioning, task switching and attention. Time taken to complete the task is recorded, with faster times indicating better cognitive performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher B Morrow, MD

CONTACT

[email protected]

410-502-6509

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Lundbeck LLC
  • National Institute on Aging (NIA)

Registry information

Official study title

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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