PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620 (NCT05456503) | Clinical Trial Compass
RecruitingPhase 3
PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620
United States72 participantsStarted 2022-09-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)
✓. Cognitively and neurologically normal according to one of the following criteria:
✓. Not clinically depressed, according to one of the following criteria:
✓. 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).
✓. Not clinically depressed, according to one of the following criteria:
✓. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.
Exclusion 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 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.
✕. 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.