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PI-2620 PET Imaging for Alzheimer's and Frontotemporal Dementia (FPI-2620 FTLD Trial)
Phase 3
Recruiting
Led By Jeffrey S Phillips
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group 1: Cognitively and neurologically normal seniors (CN, n=12)
Group 6: FTLD-TDP due to a known genetic mutation (genetic FTLD-TDP, n=3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once during single pet ct
Awards & highlights
FPI-2620 FTLD Trial Summary
This trial will compare tau PET scans from patients with FTLD, patients with naAD, and cognitively normal seniors to see if there are differences.
Who is the study for?
This trial is for men and women over 45, diagnosed with Alzheimer's or Frontotemporal Dementia (FTLD), who are not clinically depressed. Participants must be enrolled in the UNICORN study, have no early-onset neurodegenerative disease history in their family, and if female, be post-menopausal or surgically sterile. They need a study partner or legal representative.Check my eligibility
What is being tested?
The trial is testing PI-2620 tau PET scans to compare brain changes in patients with FTLD, atypical Alzheimer's (naAD), and cognitively normal seniors. It aims to understand how this imaging technique can differentiate between these conditions.See study design
What are the potential side effects?
While specific side effects of PI-2620 aren't detailed here, participants may experience discomfort or reactions related to PET scan procedures such as allergic reactions to the tracer substance used.
FPI-2620 FTLD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a senior with normal cognitive and neurological functions.
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I have a genetic form of frontotemporal dementia.
Select...
I have been diagnosed with frontotemporal lobar degeneration due to TDP-43.
Select...
I have been diagnosed with frontotemporal lobar degeneration due to tau.
Select...
I am over 45 and have a GRN gene or C9orf72 mutation.
Select...
I am a woman who is post-menopausal or have had surgery to prevent pregnancy.
Select...
I am not clinically depressed.
Select...
I am 45 or older with a MAPT gene mutation and enrolled in the UNICORN study.
Select...
My family has no history of early-onset neurodegenerative diseases.
Select...
I have a genetic form of frontotemporal dementia.
Select...
I am 45 or older and enrolled in the UNICORN study.
FPI-2620 FTLD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once during single pet ct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once during single pet ct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Regional brain SUVR
Whole brain SUVR
FPI-2620 FTLD Trial Design
7Treatment groups
Experimental Treatment
Group I: Non-amnestic Alzheimer's Disease (AD)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group II: Frontotemporal lobar degeneration from tauopathy (FLTD-tau)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group III: Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-tau)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group IV: Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of chromosome 9Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group V: Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group VI: Cognitively and neurologically normal seniors (CN)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Group VII: Amnestic Mild Cognitive Impairment Alzheimer's Disease (MCI/aAD)Experimental Treatment1 Intervention
One PET imaging scan using the PI-2620 tracer
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,137 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,804 Total Patients Enrolled
Jeffrey S PhillipsPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a senior with normal cognitive and neurological functions.I have a genetic form of frontotemporal dementia.I have been diagnosed with amnestic Alzheimer's disease.I am enrolled in a trial for a treatment targeting my neurodegenerative disease's cause.I have been diagnosed with frontotemporal lobar degeneration due to tau.I am over 45 and have a GRN gene or C9orf72 mutation.I am not clinically depressed.I am a woman who is post-menopausal or have had surgery to prevent pregnancy.I have been diagnosed with non-amnestic Alzheimer's disease.Your MRI shows a major stroke or a mass that could affect the PET scan results.I have been diagnosed with frontotemporal lobar degeneration due to TDP-43.I am 45 or older with a MAPT gene mutation and enrolled in the UNICORN study.My family has no history of early-onset neurodegenerative diseases.I have a genetic form of frontotemporal dementia.You have a history of serious alcohol or drug abuse.You have been diagnosed by a doctor with certain medical conditions.I am 45 or older and enrolled in the UNICORN study.
Research Study Groups:
This trial has the following groups:- Group 1: Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)
- Group 2: Non-amnestic Alzheimer's Disease (AD)
- Group 3: Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-tau)
- Group 4: Cognitively and neurologically normal seniors (CN)
- Group 5: Amnestic Mild Cognitive Impairment Alzheimer's Disease (MCI/aAD)
- Group 6: Frontotemporal lobar degeneration from tauopathy (FLTD-tau)
- Group 7: Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of chromosome 9
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients still needed for this research project?
"Active recruitment is underway for this study, which was originally posted on September 19th, 2020. The last update to the listing was made on October 12th, 2020."
Answered by AI
How many candidates are being offered the chance to participate in this research?
"Yes, the information on clinicaltrials.gov point out that this trial is presently recruiting candidates. The study was originally posted on 9/19/2022 and was last edited on 10/12/2022. The clinical trial is enrolling 54 patients at 1 locations"
Answered by AI
Will [18F]PI-2620 have any negative effects on patients?
"[18F]PI-2620 falls into the category of being a Phase 3 trial medication, which means that while there is some efficacy data, there is also multiple rounds of safety data. Consequently, our team at Power estimates the safety to be a 3."
Answered by AI
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