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PI-2620 PET Imaging for Alzheimer's and Frontotemporal Dementia (FPI-2620 FTLD Trial)

Phase 3

Recruiting

Led By Jeffrey S Phillips

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 1: Cognitively and neurologically normal seniors (CN, n=12)

Group 6: FTLD-TDP due to a known genetic mutation (genetic FTLD-TDP, n=3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once during single pet ct

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare tau PET scans from patients with FTLD, patients with naAD, and cognitively normal seniors to see if there are differences.

Who is the study for?

This trial is for men and women over 45, diagnosed with Alzheimer's or Frontotemporal Dementia (FTLD), who are not clinically depressed. Participants must be enrolled in the UNICORN study, have no early-onset neurodegenerative disease history in their family, and if female, be post-menopausal or surgically sterile. They need a study partner or legal representative.

What is being tested?

The trial is testing PI-2620 tau PET scans to compare brain changes in patients with FTLD, atypical Alzheimer's (naAD), and cognitively normal seniors. It aims to understand how this imaging technique can differentiate between these conditions.

What are the potential side effects?

While specific side effects of PI-2620 aren't detailed here, participants may experience discomfort or reactions related to PET scan procedures such as allergic reactions to the tracer substance used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a senior with normal cognitive and neurological functions.

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I have a genetic form of frontotemporal dementia.

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I have been diagnosed with frontotemporal lobar degeneration due to TDP-43.

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I have been diagnosed with frontotemporal lobar degeneration due to tau.

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I am over 45 and have a GRN gene or C9orf72 mutation.

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I am a woman who is post-menopausal or have had surgery to prevent pregnancy.

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I am not clinically depressed.

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I am 45 or older with a MAPT gene mutation and enrolled in the UNICORN study.

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My family has no history of early-onset neurodegenerative diseases.

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I have a genetic form of frontotemporal dementia.

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I am 45 or older and enrolled in the UNICORN study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once during single pet ct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~once during single pet ct

This trial's timeline: 3 weeks for screening, Varies for treatment, and once during single pet ct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Regional brain SUVR

Whole brain SUVR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.