RECRUITING

PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620

Conditions

Frontotemporal Lobar Degeneration Alzheimer Disease Cognitively Normal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Disease Using the PET Ligand [18F]-PI-2620

Quick Facts

Study Start:2022-09-19

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05456503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873) 2. Cognitively and neurologically normal according to one of the following criteria: 3. Not clinically depressed, according to one of the following criteria: 4. No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's self-reported history. 1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873) 2. 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 atrophy (PCA), behavioral/dysexecutive AD (bvAD), corticobasal syndrome due to AD (CBS-AD), non-amnestic mild cognitive impairment (naMCI), or non-amnestic AD (naAD). 3. Not clinically depressed, according to one of the following criteria: 4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873) 2. 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 (naPPA), corticobasal syndrome (CBS), or behavioral-variant frontotemporal dementia (bvFTD). 3. Not clinically depressed, according to one of the following criteria: 4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873) 2. 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 semantic-variant primary progressive aphasia (svPPA). 3. Not clinically depressed, according to one of the following criteria: 4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 5. 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 mutation in the GRN gene or in open reading frame 72 of chromosome 9 (C9orf72). 3. Clinically diagnosed by a trained clinician as having an appropriate neurodegenerative condition OR confirmed as an asymptomatic mutation carrier. 4. Not clinically depressed, according to one of the following criteria: 5. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873) 2. Clinically diagnosed by a trained clinician as having amnestic mild cognitive impairment (MCI) or amnestic Alzheimer's disease (aAD). 3. Not clinically depressed, according to one of the following criteria: 4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 1. 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. 2. 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 interfere with analysis of the PET scan. 3. The participant is unable to tolerate or have a contraindication to imaging procedures in the opinion of an investigator. 4. 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 within 24 hours of any scheduled PET/CT. 5. 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.) 6. The participant is enrolled in a clinical trial for a disease-modifying treatment that targets the molecular pathology underlying their neurodegenerative disease.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
2. Cognitively and neurologically normal according to one of the following criteria:
3. Not clinically depressed, according to one of the following criteria:
4. No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's self-reported history.
1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
2. 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 atrophy (PCA), behavioral/dysexecutive AD (bvAD), corticobasal syndrome due to AD (CBS-AD), non-amnestic mild cognitive impairment (naMCI), or non-amnestic AD (naAD).
3. Not clinically depressed, according to one of the following criteria:
4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
2. 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 (naPPA), corticobasal syndrome (CBS), or behavioral-variant frontotemporal dementia (bvFTD).
3. Not clinically depressed, according to one of the following criteria:
4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
2. 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 semantic-variant primary progressive aphasia (svPPA).
3. Not clinically depressed, according to one of the following criteria:
4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
5. 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 mutation in the GRN gene or in open reading frame 72 of chromosome 9 (C9orf72).
3. Clinically diagnosed by a trained clinician as having an appropriate neurodegenerative condition OR confirmed as an asymptomatic mutation carrier.
4. Not clinically depressed, according to one of the following criteria:
5. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
1. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
2. Clinically diagnosed by a trained clinician as having amnestic mild cognitive impairment (MCI) or amnestic Alzheimer's disease (aAD).
3. Not clinically depressed, according to one of the following criteria:
4. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
1. 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.
2. 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 interfere with analysis of the PET scan.
3. The participant is unable to tolerate or have a contraindication to imaging procedures in the opinion of an investigator.
4. 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 within 24 hours of any scheduled PET/CT.
5. 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.)
6. The participant is enrolled in a clinical trial for a disease-modifying treatment that targets the molecular pathology underlying their neurodegenerative disease.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

David J Irwin, MD

CONTACT

215-662-3361

dirwin@pennmedicine.upenn.edu

Jeffrey S Phillips, PhD

CONTACT

215-349-5863

jefphi@pennmedicine.upenn.edu

Principal Investigator

Jeffrey S Phillips

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Perelman Center for Advance Medicine

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Jeffrey S Phillips, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-19

Study Completion Date2028-08

Study Record Updates

Study Start Date2022-09-19

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

Frontotemporal Lobar Degeneration
Alzheimer Disease
Cognitively Normal