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

NCT06604520 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB004037961K23AG088248
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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 Lobar Dementia; Frontotemporal Degeneration; Frontotemporal Dementia (FTD); Frontotemporal Dementia, Behavioral Variant; Frontotemporal Dementia

Keywords

FTD; Frontotemporal Dementia; Neuropsychiatric Symptoms; Antidepressant

Outcome Measures

Primary Outcomes (1)

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

  Cerebral glucose uptake measured through 18F FDG positron emission tomography

  Baseline, 12 weeks

Secondary Outcomes (1)

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

  Baseline, 12 weeks

Other Outcomes (1)

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

  Baseline, 12 weeks

Study Arms (1)

Patient Treatment Arm (Vortioxetine)

EXPERIMENTAL

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

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

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

Also known as: Trintellix

Patient Treatment Arm (Vortioxetine)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator
• Lundbeck LLC: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Frontotemporal Dementia; Pick Disease of the Brain

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christopher Morrow, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher B Morrow, MD

CONTACT

410-502-6509; cmorrow3@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will shared 12 months after study starts and every 6 months thereafter. All data will be shared upon publication or at the end of the award period, whichever is sooner. For published studies, data will be shared when the pre- print is available. NACDA studies have digital object identifiers (DOI) to aid in findability. The investigators will include that DOI in relevant publications. NACDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
• Access Criteria: Given that all data will be de-identified, the investigators do not plan to control access to the data or require a Data Use Agreement. Data submitted to NACDA that are evaluated as constituting a low disclosure risk are publicly released and available to download directly from the NACDA website. The investigators plan to prepare and submit the data in a de-identified format in order to minimize any disclosure risk and allow for public release through NACDA. NACDA performs an evaluation of all submitted data prior to release to ensure disclosure risks are minimized, and the investigators anticipate approval for public release of data without restriction through the NACDA website.

Locations

US (1)