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RecruitingPhase 2

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

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

Asset

Vortioxetine

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Frontotemporal dementia

Key I/E criterion

•Age ≥45

Primary endpoint

•Global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1K23AG088248
Org study IDIRB00403796
NCT IDNCT06604520

Timeline

Milestones

Study first posted2024-09-19actual
Study start2025-03-20actual
Last update posted2026-03-09actual
Primary completion2029-05-31estimated
Study completion2029-09-01estimated

Assets

Drug assets

Vortioxetine

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

FTD Patients

Inclusion Criteria:

1. Male or Female

2. Age 45 and above

3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)

4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation

5. 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

6. Patients must be medically stable

7. Vortioxetine treatment is clinically indicated

8. Competent to provide informed consent

Exclusion criteria

1. No history of drug or alcohol dependence within six months prior to study entry

2. Negative toxicology screening for drugs of abuse

3. Subject must not be pregnant or nursing

4. No contraindications to Vortioxetine treatment

5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)

Healthy Controls

Inclusion Criteria:

1. Male or Female

2. Age 45 and above

3. Subjects must be medically stable

4. Free of psychotropic medications

5. Competent to provide informed consent

Exclusion Criteria:

1. No current or past history of neurological or psychiatric illness or substance abuse

2. Subject must not be pregnant or nursing

3. Negative toxicology screening for drugs of abuse

4. No contraindications for MR scanning (e.g. metal implanted in the body)

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Behavior / neuropsychiatric
1
Neuroimaging
1

Global cognition

1 endpoint
Other/protocol endpoint

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

Time frame:Baseline, 12 weeks

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline, 12 weeks

change from baseline, improvement

Neuroimaging

1 endpoint
Primary/protocol endpoint

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

Time frame:Baseline, 12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.