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New treatment option for Frontotemporal Lobar Degeneration
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?
[18F]-PI-2620 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for frontotemporal lobar degeneration.
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
- The investigators will compare [18F]-PI-2620 tau PET scans from patients with frontotemporal lobar degeneration (FTLD), patients with non-amnestic presentations of Alzheimer's disease (naAD), and demographically matched cognitively normal subjects.
- 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
- participants must fulfill all of the criteria for one of the following groups. 1\. Group 1: cognitively and neurologically normal people (CN, n=25)
- 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 \>...
- Not clinically depressed, according to one of the following criteria: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study...
- No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's...
You likely can't join if
- for all groups: Participants will be excluded from enrollment if they meet any of the following criteria.
- 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. A urine pregnancy test will...
- The participant has a history of significant past or ongoing alcohol abuse or substance abuse, or dependence based on medical record review or...
See the full eligibility criteria
Who can join
- participants must fulfill all of the criteria for one of the following groups. 1\. Group 1: cognitively and neurologically normal people (CN, n=25)
- 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\. Group 2: non-amnestic Alzheimer's disease...
- 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. Currently enrolled in UNICORN (IRB #842873) with a genetic test result indicating a...
- 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
- for all groups: Participants will be excluded from enrollment if they meet any of the following criteria.
- 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. A urine pregnancy test will be performed in women of child-bearing potential at screening and...
- 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's taking place
- 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 - 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?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.