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
- Are there results?
- Not yet: the study is under way
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).
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT06604520
- Acronym / sponsor ID
- IRB00403796
- Conditions
- Fronto-temporal Dementia, Fronto-temporal Lobar Dementia, Frontotemporal Degeneration, Frontotemporal Dementia (FTD), Frontotemporal Dementia, Behavioral Variant, Frontotemporal Dementia
- Keywords
- FTD, Frontotemporal Dementia, Neuropsychiatric Symptoms, Antidepressant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Lundbeck LLC
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Treatment Arm (Vortioxetine) | Experimental | Drug: VortioxetineIndividuals with bvFTD and mood symptoms receiving the study drug, vortioxetine. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: TrintellixIndividuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine | Drug | Patient Treatment Arm (Vortioxetine) |
Primary outcome
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
1 secondary outcome
Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. All de-identified data will be preserved and shared in the National Archive of Computerized Data on Aging (NACDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Morrow, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher B Morrow, MD (410-502-6509, cmorrow3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET) (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.