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

Trial Summary

What is the purpose of this trial?

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. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD? 2. 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

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 vortioxetine safe for humans?

Vortioxetine has been studied for safety in people with major depressive disorder, and these studies suggest it is generally safe for human use. ^{1 2 3 4 5}

How does the drug Vortioxetine differ from other treatments for frontotemporal dementia?

Vortioxetine is unique because it is a newer antidepressant that works by affecting multiple serotonin receptors, which may offer a different approach compared to other drugs like paroxetine and trazodone that have been studied for frontotemporal dementia. This could potentially provide a novel way to address the serotonergic deficits associated with the condition. ^{6 7 8 9 10}

Research Team

Christopher Morrow, M.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of vortioxetine in patients with major depressive disorder and comorbid Alzheimer's disease in routine clinical practice: An analysis of a post-marketing surveillance study in South Korea. [2023]

2. Switzerland 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. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Vortioxetine for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of Vortioxetine on Cognitive Impairment in Patients With Major Depressive Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of vortioxetine in patients with major depressive disorder and early-stage dementia: The MEMORY study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Paroxetine does not improve symptoms and impairs cognition in frontotemporal dementia: a double-blind randomized controlled trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Frontotemporal dementia: paroxetine as a possible treatment of behavior symptoms. A randomized, controlled, open 14-month study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Frontotemporal dementia: neurotransmitter and clinical symptoms with focus on therapeutic targets]. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment approaches to symptoms associated with frontotemporal degeneration. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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