[18F]PI-2620 for Alzheimer's Disease Detection

[18F]PI-2620 Phase 3 Histopathological Study

Recruiting Phase 3 Interventional Study
Alzheimer Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
Lantheus Biosciences Ltd. · Industry
Who this trial is looking for

This trial is looking for people aged 50 and older with advanced Alzheimer’s disease. Participants will undergo a brain imaging test to see if it can effectively detect tau buildup compared to brain analysis after death.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 50 years old or older
  • I have a life expectancy of 1 year or less as determined by my doctor
  • I can give written consent or have a legal representative who can
  • I can tolerate lying down in a PET scanner

You may not be able to join if

  • I am receiving aggressive life-sustaining treatments like chemotherapy
  • I have a structural brain lesion that would interfere with imaging
  • I have suspected brain issues due to alcoholism or liver disease
  • My kidney function is below 15 mL/min
  • I have received treatment that targets amyloid or tau
  • I am pregnant, breastfeeding, or not using adequate contraception
  • I have specific implanted medical devices that are not safe for MRI
  • I have a history of claustrophobia if an MRI is planned

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Only subjects who meet all of the following criteria will be eligible for enrollment into the study: 1. Males and females aged 50 years and over 2. Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limit…
Contacts

Audrey Perrotin, PhD

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

CONTACT

Aleksandar Jovalekic, PhD

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

CONTACT