RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, MRI scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "As part of the UNICORN study, participants are asked to undergo periodic (typically annual) magnetic resonance imaging (MRI) and clinical/neuropsychological assessment."
  • "UNICORN participants are also asked to undergo a one-time lumbar puncture to assess cerebrospinal fluid protein levels, including amyloid-ß1-42, an established biomarker for Alzheimer's disease (AD) neuropathologic change."
  • "The procedure for detecting amyloid could also be a lumbar puncture that was performed for clinical purposes or an amyloid PET scan, performed either clinically or for research purposes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares PET brain scans using a tracer called [18F]-PI-2620 to look at tau protein buildup. It includes adults with certain forms of dementia, adults with related gene changes, and adults with normal thinking and brain function.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and enrolled in the UNICORN study. Meet all rules for one study group below.
  • Have no clinical depression, based on a clinician’s exam or a Geriatric Depression Scale score of 6 or less within the past 6 months.
  • Normal brain function group: Have normal thinking and nerve function, confirmed by testing or a clinician. Have no parent or sibling with an early-starting disease that damages brain or nerve cells.
  • Alzheimer’s groups: Have a clinician’s diagnosis of likely Alzheimer’s with problems other than memory loss, or Alzheimer’s or mild thinking problems mainly involving memory loss.
  • FTLD-tau group: Have a clinician’s diagnosis of a disease that damages brain cells and is likely linked to tau protein.
  • FTLD-TDP group: Have a clinician’s diagnosis of dementia likely linked to TDP-43 protein.
  • Gene-change groups: Have a confirmed change in the MAPT, GRN, or C9orf72 gene. Have a related brain or nerve disease diagnosed by a clinician, or carry the gene change without symptoms.
  • All groups except the normal brain function group: Have a study partner who can take part, and a legally authorized representative if needed.

Who can't join

  • Have a medical or mental health condition that the study doctor believes would make the study unsafe or hard to complete.
  • Have a brain change, such as a major stroke or mass, on an MRI from less than 6 months before joining that could affect PET scan results.
  • Cannot tolerate the scans, or have a condition that makes them unsafe.
  • Be pregnant or breastfeeding at the first PET/CT scan. Those who could become pregnant must have urine pregnancy tests at screening and within 24 hours before each PET/CT scan.
  • Have a serious past or current problem with alcohol or drug misuse or dependence. The study doctor will decide whether this rules you out.
  • Be in a treatment trial that targets the underlying cause of your brain or nerve disease to change its course.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: participants must fulfill all of the criteria for one of the following groups. 1\. Group 1: cognitively and neurologically normal subjects (CN, n=25) 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: i. Mini-Mental Status Exam (MMSE; Folstein et al., 1975) score \> 27, OR ii. Montreal Cognitive Assessment (MoCA; Carson et al., 2017; Nasreddine et al., 2005) score \> 25, OR iii. Global Clinical Dementia Rating of 0, OR iv. Evaluation by a trained clinician 3. 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 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. 2\. Group 2: non-amnestic Alzheimer's disease (naAD, n=15) 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 4. 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) 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 4. 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) 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 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 MAPT gene. 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 5. Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification. 6\. Group 6: having a known genetic mutation associated with FTLD-TDP (genetic FTLD-TDP, n=3) 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 5. 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) 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: i. Geriatric Depression scale ≤ 6 (assessed ≤ 6 months prior to study enrollment), OR ii. Evaluation by a trained clinician 4. 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 for all groups: Participants will be excluded from enrollment if they meet any of the following criteria. 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.

Study sites (1)

PA