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Recruiting NCT06604520

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

Phase II Interventional Fronto-temporal Dementia Fronto-temporal Lobar Dementia Frontotemporal Degeneration Frontotemporal Dementia (FTD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vortioxetine.
Who it may be relevant to
Registry conditions: Fronto-temporal Dementia, Fronto-temporal Lobar Dementia, Frontotemporal Degeneration, Frontotemporal Dementia (FTD). Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

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

Interventions

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

Primary outcome measures

  • Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET) [Time frame: Baseline, 12 weeks]
Secondary outcome measures (1)
  • Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS). [Time frame: Baseline, 12 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT06604520 · IRB00403796 · 1K23AG088248

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗