Vortioxetine for Frontotemporal Dementia

Overseen By Christopher B Morrow, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must be taking: Vortioxetine

Must not be taking: Psychotropic medications

Disqualifiers: Neurological, Psychiatric, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vortioxetine, an antidepressant, can improve mood and thinking skills in individuals with early-stage behavioral variant Frontotemporal Dementia (bvFTD). It examines whether patients with bvFTD experience different brain and cognitive changes compared to those without the condition. Participants will receive vortioxetine for approximately 12 weeks and undergo brain scans and memory tests before and after treatment. Individuals medically diagnosed with bvFTD and experiencing mood issues such as depression or anxiety may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, healthy controls must be free of psychotropic medications, which are drugs that affect mood, perception, or behavior.

Is there any evidence suggesting that vortioxetine is likely to be safe for humans?

Research has shown that vortioxetine is generally safe and well-tolerated. In studies, patients taking vortioxetine experienced noticeable improvements in mood and daily activities. Serious side effects were rare, indicating the treatment did not cause major health issues. Some patients reported mild side effects, but these were manageable. Vortioxetine is already used to treat depression, suggesting it may be safe for other conditions as well. However, monitoring any new treatment remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for frontotemporal dementia, which often focus on managing symptoms like agitation with antipsychotics or antidepressants, vortioxetine offers a new approach. This drug is unique because it targets serotonin receptors in the brain, which could potentially improve mood and cognitive function in patients with bvFTD (behavioral variant frontotemporal dementia). Researchers are excited about vortioxetine because it might provide a dual benefit: addressing both mood symptoms and cognitive decline, which is a significant challenge in current treatment options.

What evidence suggests that vortioxetine might be an effective treatment for Frontotemporal Dementia?

Research has shown that vortioxetine can improve mood and cognitive skills in individuals with major depressive disorder. It effectively reduces depression symptoms, aids daily activities, and enhances overall mental abilities. Although limited research exists on its effects on frontotemporal dementia (bvFTD), vortioxetine's success in other conditions suggests potential benefits. This trial will assess vortioxetine's impact on mood and mental health in individuals with bvFTD, who often encounter similar challenges. Early studies suggest it may lead to positive brain changes and symptom improvement. ^{2 3 6 7 8}

Who Is on the Research Team?

Christopher Morrow, M.D.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage behavioral variant Frontotemporal Dementia (bvFTD) who experience mood symptoms. Participants must undergo clinical assessments, laboratory tests, brain imaging, and cognitive testing before and after a 12-week treatment period.

Inclusion Criteria

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

I am 45 years old or older.

Exclusion Criteria

Negative toxicology screening for drugs of abuse

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

History of drug or alcohol dependence within six months prior to study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo initial brain MRI, FDG PET scan, and memory and problem-solving tests before starting treatment

1 week

1 visit (in-person)

Treatment

Participants receive approximately 12 weeks of treatment with vortioxetine, with regular contact and assessments

12 weeks

Regular visits (in-person and virtual)

Post-Treatment Assessment

Participants undergo repeat PET scan and memory and problem-solving tests after treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vortioxetine

Trial Overview The study is testing whether vortioxetine can improve mood and cognitive functions in bvFTD patients. It involves initial and follow-up brain scans (MRI & FDG PET) as well as memory and problem-solving tests to measure changes after the treatment.

How Is the Trial Designed?

Group I: Patient Treatment Arm (Vortioxetine) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Lundbeck LLC

Industry Sponsor

Trials

17

Recruited

10,600+

Published Research Related to This Trial

In a study involving 3,263 patients treated with vortioxetine for major depressive disorder in South Korea, the medication demonstrated a favorable safety profile, with only 17.13% reporting any adverse events, most of which were mild.

Vortioxetine was found to be effective, with significant improvements in depression symptoms observed in 1,918 patients after approximately 24 weeks, as indicated by various clinical and patient-reported measures, showing consistent efficacy across different age groups and sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of vortioxetine for major depressive disorder: Real-world evidence from a population-based study in South Korea. Moon, SW., Kim, JW., Kim, DH., et al.[2023]

Despite the lack of large-scale treatment trials for frontotemporal dementia (FTD), various drugs have shown some improvement in symptoms, with trazodone, SSRIs, and methylphenidate among those reported to be effective.

There is a need for consensus on standards for future clinical trials in FTD, including diagnostic criteria and outcome measures, to facilitate better comparison and evaluation of therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frontotemporal dementia: recommendations for therapeutic studies, designs, and approaches. Freedman, M.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06604520

Vortioxetine for the Treatment of Mood and Cognitive ... The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723007905

Effectiveness of vortioxetine in patients with major ... Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625954/

Expert opinions on pharmacological symptomatic treatment ... Our survey revealed diverse pharmacological treatment practices for behavioral symptoms in bvFTD, reflecting the expected radical heterogeneity ...

4. clinicaltrial.be clinicaltrial.be/en/details/449737?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Vortioxetine for the Treatment of Mood and Cognitive Symp... The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral ...

5. withpower.com withpower.com/trial/phase-2-alzheimer-disease-10-2024-c6a6c

Vortioxetine for 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433453/

Effectiveness of Vortioxetine Treatment on Depression and ... Patients also experienced significant improvements in daily and global functioning. Vortioxetine was safe and well tolerated. Patients with AD ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/ene.16537

Expert opinions on pharmacological symptomatic treatment ... The aim of this study is to explore currently preferred clinical practices in the pharmacological treatment of specific core behavioral symptoms in bvFTD by ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10720213/

Real-world clinical outcomes and treatment patterns in ... Our study results suggest that adults with MDD prescribed vortioxetine showed improvement in depressive symptoms in the context of a real-world clinical ...