PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
No history of early-onset neurodegenerative disease in biological siblings or parents, based on the investigators' assessment of the participant's self-reported history.
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 atrophy (PCA), behavioral/dysexecutive AD (bvAD), corticobasal syndrome due to AD (CBS-AD), non-amnestic mild cognitive impairment (naMCI), or non-amnestic AD (naAD).
Disqualifiers
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 interfere with analysis of the PET scan.
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 within 24 hours of any scheduled PET/CT.
Trial design
Design model
Parallel
Treatments tested in this trial
[18F]-PI-2620
DrugRadiotracer
Treatment groups
72 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Cognitively and neurologically normal adults (CN)Experimental treatment 1 intervention
Group B: Non-amnestic Alzheimer's Disease (AD)Experimental treatment 1 intervention
Group C: Frontotemporal lobar degeneration from tauopathy (FLTD-tau)Experimental treatment 1 intervention
Group D: Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)Experimental treatment 1 intervention
Group E: Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-tau)Experimental treatment 1 intervention
Group F: Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of chromosome 9Experimental treatment 1 intervention
Group G: Amnestic Mild Cognitive Impairment Alzheimer's Disease (MCI/aAD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Whole brain SUVR
Whole-brain and regionally specific standardized uptake value ratio (SUVR) calculated over a 30 minute imaging period beginning 45 minutes (groups 1, 2, 4, 6, \& 7) after tracer injection
Time frame
Once during single PET CT2
Regional brain SUVR
Regionally specific standardized uptake value ratio (SUVR) calculated over a 30 minute period beginning at either 30 minutes (groups 3 \& 5 plus half of group 1) or 45 minutes (groups 2, 4, \& 6 \& 7 plus half of group 1) after PET imaging tracer injection.
Time frame
Once during single PET CTSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov