Fronto-temporal DementiaPhase 2NCT06604520
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
A Phase 2 study testing Vortioxetine in people with Fronto-temporal Dementia and Fronto-temporal Lobar Dementia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fronto-temporal Dementia, Fronto-temporal Lobar Dementia, Frontotemporal Degeneration
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 1 Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Vortioxetine treatment is clinically indicated
- Competent to provide informed consent
- Male or Female
- Age 45 and above
- Subjects must be medically stable
- Free of psychotropic medications
- Competent to provide informed consent
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Christopher B Morrow, MD, 410-502-6509, cmorrow3@jhmi.edu
Christopher B Morrow, MD
About this study
Official title: Functional Neuroimaging to Examine Affective Symptoms and Cognition 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:
- Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD?
- Do mood symptoms and cognition improve following treatment with vortioxetine?
Read more
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
- Being tested
- Vortioxetine
- Keywords
- FTD, Frontotemporal Dementia, Neuropsychiatric Symptoms, Antidepressant
- Medical subject headings
- Frontotemporal Dementia, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Trintellix
Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine
| Study group | Role | What they receive |
|---|---|---|
| Patient Treatment Arm (Vortioxetine) | Experimental | Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
Cerebral glucose uptake measured through 18F FDG positron emission tomography
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Mar 2025
- Primary completion31 May 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fronto-temporal DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Lundbeck LLC
- Responsible party
- Sponsor
- Investigators
- Christopher Morrow, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604520
- Sponsor's protocol ID
- IRB00403796
- Other IDs
- 1K23AG088248
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be preserved and shared in the National Archive of Computerized Data on Aging (NACDA).