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Virus Therapy
PR006 for Frontotemporal Dementia (PROCLAIM Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Prevail Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient and/or patient's legally authorized representative has the ability to understand the purpose and risks of the study, and provide written informed consent and authorization to use protected health information.
Body weight range of ≥40 kg (88 lbs) to ≤110 kg (242 lb) and a BMI of 18 to 34 kg/m2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
PROCLAIM Trial Summary
This trial is testing a new treatment for frontotemporal dementia, which is a progressive brain disorder. The treatment is called PR006 and it will be given to patients through a series of injections. The goal of the trial is to see if PR006 is safe and effective in treating frontotemporal dementia.
Who is the study for?
This trial is for adults aged 30-85 with frontotemporal dementia due to progranulin gene mutations. Participants must be living in the community, not dependent on a walker or wheelchair, have up-to-date vaccinations and cancer screenings, and test negative for tuberculosis. They need a reliable informant to report on their health status.Check my eligibility
What is being tested?
The study tests LY3884963's safety and its effect on protein levels related to dementia when administered into the spinal fluid. Optional treatments include Sirolimus and Prednisone. Over five years, patients will be monitored through various doses of LY3884963 for changes in biomarkers and clinical outcomes.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, immune system responses due to drug components like corticosteroids or sirolimus, as well as general risks associated with anesthesia required during administration.
PROCLAIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study's risks and can give my consent.
Select...
My weight is between 88 and 242 lbs, and my BMI is between 18 and 34.
Select...
I do not rely on a walker or wheelchair to move around.
Select...
I have been diagnosed with frontotemporal dementia and have symptoms.
Select...
I carry a mutation in the progranulin gene.
Select...
I am between 30 and 85 years old.
Select...
I carry a mutation in the GRN gene.
PROCLAIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in AAV9 immunogenicity in blood
Change in AAV9, PGRN, and NfL immunogenicity in CSF
Change in PGRN immunogenicity in CSF
+7 moreSecondary outcome measures
Change in CDR plus NACC FTLD
Change in NfL levels in CSF
Change in NfL levels in blood
PROCLAIM Trial Design
4Treatment groups
Experimental Treatment
Group I: Initial Cohort - Medium doseExperimental Treatment4 Interventions
Group II: Initial Cohort - Low doseExperimental Treatment4 Interventions
Group III: Bridging Cohort - Medium doseExperimental Treatment4 Interventions
Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner
Group IV: Bridging Cohort - Low doseExperimental Treatment4 Interventions
Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280
Find a Location
Who is running the clinical trial?
Prevail TherapeuticsLead Sponsor
3 Previous Clinical Trials
50 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,619 Previous Clinical Trials
3,206,576 Total Patients Enrolled
Olga Uspenskaya-Cadoz, MD, PhDStudy DirectorPrevail Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the CDR plus NACC FTLD sum of boxes test is between 0.5 and 15.I have had the pneumonia and shingles vaccines within the last 10 years.I understand the study's risks and can give my consent.My weight is between 88 and 242 lbs, and my BMI is between 18 and 34.I have a brain condition that is not frontotemporal dementia but could cause similar symptoms.I am allergic or cannot take corticosteroid or sirolimus.You have abnormal test results that are important for your health.I have been on the same medication for at least 8 weeks before starting PR006A.I do not rely on a walker or wheelchair to move around.I cannot undergo general anesthesia or deep sedation due to health risks.I have not used blood thinners in the last 2 weeks and can stop antiplatelet therapy as required.I have not received any live vaccines in the last 4 weeks, except for pneumococcal or shingles vaccines.You must have a recent test showing that you don't have tuberculosis.I haven't been in a drug/device study for FTD in the last 3 months, or I only received a placebo.I have not changed my medications for the last 8 weeks.I have not had any gene or cell therapy before.You cannot have certain types of medical imaging, like MRI or CT scans, because of allergies or other issues.You have tested positive for illegal drugs in your urine during screening or on the first day of the study.I have been diagnosed with frontotemporal dementia and show symptoms like changes in behavior, thinking, movement, or speech.I have been diagnosed with frontotemporal dementia and have symptoms.My cancer screenings are current and match my age and gender.I carry a mutation in the progranulin gene.I am between 30 and 85 years old.I experience numbness or tingling in both sides of my body equally.My brain or spine MRI shows I can't have an ICM injection.My cancer screenings are current for my age and gender.I carry a mutation in the GRN gene.
Research Study Groups:
This trial has the following groups:- Group 1: Initial Cohort - Low dose
- Group 2: Initial Cohort - Medium dose
- Group 3: Bridging Cohort - Low dose
- Group 4: Bridging Cohort - Medium dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Frontotemporal Dementia Patient Testimony for trial: Trial Name: NCT04408625 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the patients in this trial older than 35 years of age?
"In order to meet the requirements for this particular study, applicants must be between 30 and 80 years of age. Out of the 1459 total clinical trials being conducted, 203 are for patients younger than 18 while 1156 are focused on those who are over 65."
Answered by AI
Could I join the ranks of this clinical trial's participants?
"This clinical trial is looking for 15 people aged 30-80 who have semantic dementia. To be eligible, applicants must: -Have been using background medications regularly for at least 8 weeks before PR006A dosing. -Be a carrier of a pathogenic GRN (progranulin gene) mutation. -Have a negative screening test for Mycobacterium tuberculosis (MTB) or have had a documented negative MTB test within 1 year prior to screening. -Be up to date with age- and gender-appropriate cancer screenings. -Have a reliable study partner/"
Answered by AI
Does PR006 have a history of being studied in other medical trials?
"PR006 was first studied in 1993 at National Institutes of Health Clinical Center. So far, there have been a total of 1764 completed trials and 852 active ones. Many of the ongoing trials are based out of Philadelphia, USA."
Answered by AI
What are the common treatments that PR006 is used for?
"PR006 has shown to be effective in the treatment of scalp structure, organ transplantation, and thyroiditis."
Answered by AI
How many test subjects are part of this research project?
"The correct answer is that this trial, as advertised on clinicaltrials.gov, is still looking for patients to enroll. The posting date was November 9th 2020 with the most recent update being July 1st 2022. They are hoping to have a total of 15 people participate at 2 different locations."
Answered by AI
Are researchers looking for new participants in this trial?
"The trial, as profiled on clinicaltrials.gov, is still looking for participants. The posting went up on November 9th 2020 and was last updated July 1st, 2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Hospital of the University of Pennsylvania, 3 West Gates Building, 3400 Spruce Street
University College London,Queen Square, Dementia Research Building, London,
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Iowa
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Have tried what is out there now.They are not hopeful, no cure. Want to help find a cure. No one in our state has any answers.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- University College London,Queen Square, Dementia Research Building, London,: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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