PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620

Description

The investigators will compare 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 seniors.

Conditions

Frontotemporal Lobar Degeneration, Alzheimer Disease, Cognitively Normal

Study Overview

Study Details

Study overview

The investigators will compare 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 seniors.

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

PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620

Condition
Frontotemporal Lobar Degeneration
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Perelman Center for Advance Medicine, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female ≥ 45 years of age currently enrolled in UNICORN (IRB #842873)
  • 2. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 3. Cognitively and neurologically normal according to one of the following criteria:
  • 4. Not clinically depressed, according to one of the following criteria:
  • 5. 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 ≥ 45 years of age currently enrolled in UNICORN (IRB #842873)
  • 2. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 3. Clinically diagnosed by a trained clinician as having logopenic-variant primary progressive aphasia (lvPPA) or posterior cortical atrophy (PCA).
  • 4. Not clinically depressed, according to one of the following criteria:
  • 5. Have a study partner or legally authorized representative who can accompany the participant for all screening and study activities.
  • 3. Group 3: FTLD due to tau (FTLD-tau, n=12)
  • 1. Male or female ≥ 45 years of age currently enrolled in UNICORN (IRB #842873)
  • 2. If female, post-menopausal or surgically sterile. (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 3. Clinically diagnosed by a trained clinician as having progressive supranuclear palsy (PSP), non-fluent agrammatic primary progressive aphasia (naPPA), or behavioral-variant frontotemporal dementia (bvFTD) consistent with Pick's disease.
  • 4. Not clinically depressed, according to one of the following criteria:
  • 5. Have a study partner or legally authorized representative who can accompany the participant for all screening and study activities.
  • 4. Group 4: FTLD due to TDP-43 (FTLD-TDP, n=12)
  • 1. Male or female ≥ 45 years of age currently enrolled in UNICORN (IRB #842873)
  • 2. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 3. Clinically diagnosed by a trained clinician as having amyotropic lateral sclerosis with frontotemporal dementia (ALS-FTD) or semantic-variant primary progressive aphasia (svPPA).
  • 4. Not clinically depressed, according to one of the following criteria:
  • 5. Have a study partner or legally authorized representative who can accompany the participant for all screening and study activities.
  • 5. Group 5: FTLD-tau due to a known genetic mutation (genetic FTLD-tau, n=3)
  • 1. Male or female ≥ 45 years of age
  • 2. Currently enrolled in UNICORN (IRB #842873) with a genetic test result indicating a mutation in the MAPT gene.
  • 3. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 4. Clinically diagnosed by a trained clinician as having progressive supranuclear palsy (PSP), non-fluent agrammatic primary progressive aphasia (naPPA), or behavioral-variant frontotemporal dementia (bvFTD) consistent with Pick's disease.
  • 5. Not clinically depressed, according to one of the following criteria:
  • 6. Have a study partner or legally authorized representative who can accompany the participant for all screening and study activities.
  • 6. Group 6: FTLD-TDP due to a known genetic mutation (genetic FTLD-TDP, n=3)
  • 1. Male or female ≥ 45 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. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 4. Clinically diagnosed by a trained clinician as having amyotropic lateral sclerosis with frontotemporal dementia (ALS-FTD) or semantic-variant primary progressive aphasia (svPPA)
  • 5. Not clinically depressed, according to one of the following criteria:
  • 6. Have a study partner or legally authorized representative who can accompany the participant for all screening and study activities.
  • 7. Group 7: amnestic Alzheimer's disease (naAD, n=15)
  • 1. Male or female ≥ 45 years of age currently enrolled in UNICORN (IRB #842873) 2. If female, post-menopausal or surgically sterile (i.e., unable to have children due to hysterectomy, removal of the Fallopian tubes, tubal ligation, or similar surgery).
  • 3. Clinically diagnosed by a trained clinician as having amnestic mild cognitive impairment (MCI) or amnestic Alzheimer's disease (aAD).
  • 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 or legally authorized representative who can accompany the participant for all screening and study activities.
  • 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 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. The participant has a history of significant or ongoing alcohol abuse or substance abuse, or dependence based on medical record review or self-reported.
  • 5. The participant is enrolled in a clinical trial for a disease-modifying treatment that targets the molecular pathology underlying their neurodegenerative disease.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Pennsylvania,

Jeffrey S Phillips, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2028-08