Frontotemporal Lobar Degeneration study: [18F]-PI-2620
Official title PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620
ClinicalTrials.gov ID: NCT05456503
What this study is testing
What is [18F]-PI-2620?
This is an investigational radiotracer being studied to help identify brain changes in frontotemporal lobar degeneration. is designed to bind to tau protein in the brain so it can be seen on a PET scan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new PET scan tracer can show differences in tau protein in frontotemporal disease and non‑memory Alzheimer’s compared to healthy people.
- Who it's for
- You may be able to join if you have frontotemporal disease, a non‑memory form of Alzheimer’s, or you are a healthy adult with no cognitive problems.
- What's involved
- You will have a PET scan that uses a special tracer to look for tau protein. The scan is done at a research center and you will stay for a few hours. No medication is given.
- Time commitment
- The study lasts one visit, which takes about 3 to 4 hours.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Cognitively and neurologically normal according to one of the following criteria: i. Mini-Mental Status Exam (MMSE
- Not clinically depressed, according to one of the following criteria: i.
- No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's...
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
You likely can't join if
- The participant has any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the participant's safety or...
- The investigators of UNICORN (IRB #842873) have determined the participant has evidence of structural abnormalities such as major stroke or mass on...
- The participant is unable to tolerate or have a contraindication to imaging procedures in the opinion of an investigator.
- Females who are pregnant or breast feeding at the time of the baseline PET/CT scan will not be eligible for this study.
- The participant has a history of significant past or ongoing alcohol abuse or substance abuse, or dependence based on medical record review or...
- The participant is enrolled in a clinical trial for a disease-modifying treatment that targets the molecular pathology underlying their...
See the full eligibility criteria
Who can join
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Cognitively and neurologically normal according to one of the following criteria: i. Mini-Mental Status Exam (MMSE; Folstein et al., 1975) score \> 27, OR ii. Montreal Cognitive Assessment (MoCA; Carson et al., 2017
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's self-reported history. 2\.
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Clinically diagnosed by a trained clinician as having a non-amnestic syndrome attributed to likely AD pathology, including but not limited to logopenic-variant primary progressive aphasia (lvPPA), posterior cortical...
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 3\. Group 3: FTLD likely due to tau (FTLD-tau, n=25)
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Clinically diagnosed by a trained clinician as having a neurodegenerative syndrome likely due to tau , including but not limited to progressive supranuclear palsy (PSP), non-fluent agrammatic primary progressive aphasia...
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 4\. Group 4: FTLD likely due to TDP-43 (FTLD-TDP, n=12)
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Clinically diagnosed by a trained clinician as having a dementia syndrome associated with likely TDP-43 pathology, including but not limited to amyotrophic lateral sclerosis with frontotemporal dementia (ALS-FTD) or...
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
- Group 5: having a known genetic mutation associated with FTLD-tau (genetic FTLD-tau, n=12) 1\. Male or female ≥ 18 years of age 2.
- Male or female ≥ 18 years of age
- Currently enrolled in UNICORN (IRB #842873) with a genetic test result indicating a mutation in the GRN gene or in open reading frame 72 of chromosome 9 (C9orf72).
- Clinically diagnosed by a trained clinician as having an appropriate neurodegenerative condition OR confirmed as an asymptomatic mutation carrier.
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 7\. Group 7: amnestic Alzheimer's disease (naAD, n=15)
- Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
- Clinically diagnosed by a trained clinician as having amnestic mild cognitive impairment (MCI) or amnestic Alzheimer's disease (aAD).
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician
- Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
What rules you out
- The participant has any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the participant's safety or successful participation in the study.
- The investigators of UNICORN (IRB #842873) have determined the participant has evidence of structural abnormalities such as major stroke or mass on MRI scan within \< 6 months prior to enrollment that is likely to...
- The participant is unable to tolerate or have a contraindication to imaging procedures in the opinion of an investigator.
- Females who are pregnant or breast feeding at the time of the baseline PET/CT scan will not be eligible for this study.
- The participant has a history of significant past or ongoing alcohol abuse or substance abuse, or dependence based on medical record review or self-reported (may be excluded at the discretion of the investigator.)
- The participant is enrolled in a clinical trial for a disease-modifying treatment that targets the molecular pathology underlying their neurodegenerative disease.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.