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Verdiperstat for Frontotemporal Dementia (Veri-T-001 Trial)
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.
Veri-T-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVeri-T-001 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 & 3 trial • 167 Patients • NCT04436510Veri-T-001 Trial Design
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Who is running the clinical trial?
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- Your blood tests show low neutrophil count, low platelet count, high serum creatinine, high total bilirubin, high alanine aminotransferase, high aspartate aminotransferase, or high international normalized ratio.Your kidney function, as measured by eGFR, is very low, and your serum creatinine or Hemoglobin A1C levels are too high.I have been diagnosed with Alzheimer's disease based on specific tests.I have no GI diseases or surgeries that affect drug absorption.I haven't had a heart attack or been hospitalized for heart issues in the last year.I have not had major surgery in the last four weeks.My thyroid disease is not under control, with abnormal T4 and very high TSH levels.I have had a serious infection within the last month.I have previously been treated with verdiperstat.My condition is linked to specific genetic mutations but not TDP-43.I cannot undergo an LP due to certain conditions or medications, except for stable low-dose aspirin use.I can swallow pills whole without needing to crush or chew them.Your heart's electrical activity (measured by an ECG) shows specific irregularities that could prevent you from joining the study.I have been diagnosed with a specific type of dementia that is not svPPA.I do not have a history of serious heart, blood, kidney, or liver diseases.I haven't taken strong CYP1A2 inhibitors like ciprofloxacin recently.My MRI shows svPPA without major strokes or severe brain damage.My medications for Alzheimer's and mental health have been stable for 2 months.You have symptoms that match the guidelines for a specific type of brain condition called svPPA.Your CDR® plus NACC FTLD (Miyagawa et al. 2020) global score at screening needs to be 1 or less.I have not had a blood transfusion in the last 4 weeks.My cancer was diagnosed within the last 5 years, excluding skin cancer.I haven't taken steroids or immune-weakening drugs in the last 30 days.I agree to use contraception or abstain from sex with women of childbearing potential during and for 90 days after the study.I have a serious autoimmune disease or a condition that weakens my immune system.I do not have any medical conditions like uncontrolled seizures or substance abuse that could explain my cognitive or behavioral issues.I am between 18 and 85 years old.I have undergone stem cell treatment.I do not have a significant viral infection, including HIV.
- Group 1: Verdiperstat
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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