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Verdiperstat for Frontotemporal Dementia (Veri-T-001 Trial)

Phase 1
Recruiting
Research Sponsored by Peter Ljubenkov, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow pills whole without crushing or chewing
MRI at screening is consistent with the underlying svPPA with no large strokes or severe white matter disease (Fazekas Grade ≤2; Fazekas et al. 1987)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Veri-T-001 Trial Summary

This trial is testing a new drug to see if it is safe and works well in patients with a certain type of dementia.

Who is the study for?
This trial is for adults aged 18-85 with semantic variant primary progressive aphasia due to TDP-43 pathology. Participants must be able to swallow pills, have a study partner, and agree to contraception if of childbearing potential. Exclusions include significant cardiovascular, renal or hepatic disease; recent immunosuppressants use; certain blood disorders; uncontrolled thyroid disease; major psychiatric illness; and known sensitivity to Verdiperstat's ingredients.Check my eligibility
What is being tested?
The Veri-T trial is testing the safety and effectiveness of Verdiperstat taken twice daily by patients with svPPA due to FTLD-TDP. The study will last for 24 weeks where three-fourths of participants receive Verdiperstat and one-fourth receive a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns in trials like this may include digestive issues, potential allergic reactions, changes in mood or behavior, fatigue, headaches or other neurological symptoms.

Veri-T-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills whole without needing to crush or chew them.
Select...
My MRI shows svPPA without major strokes or severe brain damage.
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My medications for Alzheimer's and mental health have been stable for 2 months.
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I agree to use contraception or abstain from sex with women of childbearing potential during and for 90 days after the study.
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I am between 18 and 85 years old.

Veri-T-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Changes in Pharmacokinetic properties of Verdiperstat in Cerebrospinal Fluid (CSF)
Changes in Pharmacokinetic properties of Verdiperstat in Plasma
Other outcome measures
Change in Clinical Dementia Rating Scale (CDR-SB)
Change in Executive brain function
Change in brain volume on brain MRI
+7 more

Side effects data

From 2022 Phase 2 & 3 trial • 167 Patients • NCT04436510
28%
Nausea
21%
Headache
20%
Insomnia
19%
Constipation
19%
Fall
17%
Muscular weakness
16%
Fatigue
13%
Neuromyopathy
10%
Dizziness
10%
Dysphagia
10%
Tension headache
10%
Decreased appetite
9%
Blood thyroid stimulating hormone increased
8%
Salivary hypersecretion
8%
Diarrhoea
8%
Dyspnoea
8%
Urinary tract infection
7%
Anxiety
6%
Back pain
6%
Urine odour abnormal
6%
Oedema peripheral
6%
Cough
6%
Arthralgia
3%
Pain in extremity
3%
Dysarthria
2%
Pulmonary embolism
2%
Amyotrophic lateral sclerosis
2%
Respiratory failure
2%
Febrile neutropenia
1%
Aphasia
1%
Cerebral infarction
1%
Bacteraemia
1%
Bacterial sepsis
1%
COVID-19
1%
COVID-19 pneumonia
1%
Failure to thrive
1%
Sudden death
1%
Hip fracture
1%
Hepatic enzyme abnormal
1%
B-cell lymphoma
1%
Acute respiratory failure
1%
Abdominal pain
1%
Ileus
1%
Dehydration
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Verdiperstat
Matching Placebo

Veri-T-001 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VerdiperstatExperimental Treatment1 Intervention
Verdiperstat 2 tablets twice daily (600mg total daily) by mouth for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo 2 tablets twice daily by mouth for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verdiperstat
2019
Completed Phase 3
~610

Find a Location

Who is running the clinical trial?

Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,699 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,732 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,659 Previous Clinical Trials
28,004,705 Total Patients Enrolled

Media Library

Verdiperstat (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05184569 — Phase 1
Semantic Dementia Research Study Groups: Verdiperstat, Placebo
Semantic Dementia Clinical Trial 2023: Verdiperstat Highlights & Side Effects. Trial Name: NCT05184569 — Phase 1
Verdiperstat (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05184569 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room to enroll in this experiment?

"As visible on clinicaltrials.gov, the team is currently recruiting candidates for this medical trial which was first posted in April 2022 and most recently updated in October of that same year."

Answered by AI

Is eligibility for this clinical experiment limited to subjects under 35 years of age?

"The requirements to be considered eligible for this trial demand a patient age between 18 and 85. There are 7 separate trials tailored towards youth, while 57 have been specifically designed for those aged above 65 years old."

Answered by AI

Am I able to register for this research study?

"Eligible participants should have a diagnosis of brain disease and be aged between 18 - 85 years old. Approximately 64 individuals will join the study in total."

Answered by AI

How many participants will be involved in this research endeavor?

"Affirmative. Clinicaltrials.gov data suggests the this medical research, which was first published on April 14th 2022, is actively recruiting participants. Specifically, 64 individuals need to be recruited from a single site."

Answered by AI

Has Verdiperstat received the endorsement of the Food and Drug Administration?

"Since this is a Phase 1 clinical trial, there exists minimal evidence of safety and efficacy for Verdiperstat. Therefore it was assigned an overall rating of 1."

Answered by AI
~35 spots leftby Jun 2026