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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 1\. Group 1: cognitively and neurologically normal subjects (CN, n=25)

• Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)

• 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

• 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

• 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)

• Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)

• Clinically diagnosed by a trained clinician as having logopenic-variant primary progressive aphasia (lvPPA) or posterior cortical atrophy (PCA).

• 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

• 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)

• Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)

• 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.

• 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

• 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)

• Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)

• Clinically diagnosed by a trained clinician as having amyotrophic lateral sclerosis with frontotemporal dementia (ALS-FTD) or semantic-variant primary progressive aphasia (svPPA).

• 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

• Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.

• 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)

• Male or female ≥ 18 years of age

• 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).

• Clinically diagnosed by a trained clinician as having an appropriate neurodegenerative condition OR confirmed as an asymptomatic mutation carrier.

• 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

• 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)

• Male or female ≥ 18 years of age currently enrolled in UNICORN (IRB #842873)

• Clinically diagnosed by a trained clinician as having amnestic mild cognitive impairment (MCI) or amnestic Alzheimer's disease (aAD).

• 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

• Have a study partner and LAR (if applicable) who can participate as outlined in the protocol. Please see page 15 for further clarification.

Locations
United States
Pennsylvania
Perelman Center for Advance Medicine
RECRUITING
Philadelphia
Contact Information
Primary
David J Irwin, MD
dirwin@pennmedicine.upenn.edu
215-662-3361
Backup
Jeffrey S Phillips, PhD
jefphi@pennmedicine.upenn.edu
215-349-5863
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2028-08
Participants
Target number of participants: 72
Treatments
Experimental: Cognitively and neurologically normal adults (CN)
One PET imaging scan using the PI-2620 tracer
Experimental: Non-amnestic Alzheimer's Disease (AD)
One PET imaging scan using the PI-2620 tracer
Experimental: Frontotemporal lobar degeneration from tauopathy (FLTD-tau)
One PET imaging scan using the PI-2620 tracer
Experimental: Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)
One PET imaging scan using the PI-2620 tracer
Experimental: Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-tau)
One PET imaging scan using the PI-2620 tracer
Experimental: Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of chromosome 9
One PET imaging scan using the PI-2620 tracer
Experimental: Amnestic Mild Cognitive Impairment Alzheimer's Disease (MCI/aAD)
One PET imaging scan using the PI-2620 tracer
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov

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