200 Participants Needed

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

Recruiting at 22 trial locations
AP
AJ
Overseen ByAleksandar Jovalekic, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Life Molecular Imaging Ltd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests a brain scan that uses a special substance to detect harmful proteins in people with Alzheimer's disease.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving aggressive treatment with life-sustaining measures like chemotherapy, you may not be eligible to participate.

What data supports the effectiveness of the drug [18F]PI-2620 for Alzheimer's Disease?

Research shows that [18F]PI-2620 is effective in detecting tau deposits, which are linked to Alzheimer's Disease, using PET imaging. It has been shown to provide clear images that help distinguish between Alzheimer's patients and healthy individuals, and its uptake in the brain correlates with cognitive impairment levels.12345

Is [18F]PI-2620 safe for use in humans?

Initial clinical data show that [18F]PI-2620 is safe and well tolerated in humans, with no significant safety concerns reported during studies involving Alzheimer's disease patients and healthy controls.12346

How is the drug [18F]PI-2620 different from other Alzheimer's treatments?

[18F]PI-2620 is unique because it is a PET imaging tracer specifically designed to bind to tau proteins, which are a hallmark of Alzheimer's disease, allowing for the visualization of tau deposits in the brain. This helps in diagnosing and understanding the progression of Alzheimer's, unlike traditional treatments that focus on symptom management.12347

Research Team

AS

Andrew Stephens, MD, PhD

Principal Investigator

Life Molecular Imaging

AA

Alireza Atri, MD, PhD

Principal Investigator

Banner Health

Eligibility Criteria

This trial is for men and women over 50 with Alzheimer's or terminal conditions like end-stage dementia, who are not on aggressive life-sustaining treatments, have a life expectancy of ≤1 year, can lie in a PET scanner, and consent to brain donation after death. Pregnant women or those without proper contraception are excluded.

Inclusion Criteria

I have given my written consent for study procedures and brain donation.
Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limited to end-stage dementia, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease (COPD), or end-stage cancer)
I am 50 years old or older.
See 1 more

Exclusion Criteria

Are known to have a Glomerular Filtration Rate below < 15 mL/min
I might have brain issues due to heavy drinking or severe liver disease.
I am a woman who could get pregnant and am not using birth control, or I am pregnant or breastfeeding.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo PET imaging with [18F]PI-2620 to detect tau deposition

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after PET imaging

1 year

Treatment Details

Interventions

  • [18F]PI-2620
Trial Overview[18F]PI-2620 is being tested for its ability to detect tau protein deposits in the brain using PET imaging. Participants will be compared with post-mortem histopathology results to assess the accuracy of this method in living subjects versus autopsy findings.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PI-2620 PET ScanExperimental Treatment1 Intervention

[18F]PI-2620 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as 18F-PI-2620 for:
  • Detection of tau deposition in Alzheimer's disease
🇪🇺
Approved in European Union as 18F-PI-2620 for:
  • Detection of tau deposition in Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Life Molecular Imaging Ltd

Lead Sponsor

Trials
1
Recruited
200+

Findings from Research

The study found that the tau-binding radiotracer [18F]PI-2620 showed significantly higher uptake in the brains of Alzheimer's disease (AD) patients compared to cognitively normal individuals and those with mild cognitive impairment (MCI), indicating its potential as a diagnostic tool for differentiating AD from other cognitive states.
The analysis revealed specific brain regions, such as the occipital lobe and fusiform gyrus, where tau protein deposits were more pronounced in AD patients, aligning with known Braak Stages of tau pathology, which could help in identifying and understanding the progression of Alzheimer's disease.
The Evaluation of Tau Deposition with [18F]PI-2620 by Using a Semiquantitative Method in Cognitively Normal Subjects and Patients with Mild Cognitive Impairment and Alzheimer's Disease.Jantarato, A., Vachatimanont, S., Boonkawin, N., et al.[2021]
The novel tau-PET radiotracer [18F]PI-2620 shows strong potential as a surrogate biomarker for neuronal injury, correlating well with traditional [18F]FDG-PET imaging in a study of 26 subjects with suspected tauopathies.
Early-phase imaging of [18F]PI-2620 (0.5 to 2.5 minutes post-injection) demonstrated high agreement with [18F]FDG-PET, suggesting that it could replace the need for additional [18F]FDG-PET imaging in assessing both tau distribution and neuronal injury.
Early-phase [18F]PI-2620 tau-PET imaging as a surrogate marker of neuronal injury.Beyer, L., Nitschmann, A., Barthel, H., et al.[2022]
The study involved 74 subjects with mild cognitive impairment or mild Alzheimer's disease, showing that tau deposition measured by 18F-PI-2620 PET correlates with amyloid-beta levels and cerebrospinal fluid biomarkers, indicating its potential as a marker for neurodegeneration in Alzheimer's disease.
Over a 12-month period, significant increases in tau load were observed in specific brain regions, suggesting that 18F-PI-2620 PET can effectively track tau pathology and its association with cognitive decline in early Alzheimer's disease.
Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study.Bullich, S., Mueller, A., De Santi, S., et al.[2022]

References

The Evaluation of Tau Deposition with [18F]PI-2620 by Using a Semiquantitative Method in Cognitively Normal Subjects and Patients with Mild Cognitive Impairment and Alzheimer's Disease. [2021]
Early-phase [18F]PI-2620 tau-PET imaging as a surrogate marker of neuronal injury. [2022]
Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. [2022]
Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study. [2022]
Feasibility of short imaging protocols for [18F]PI-2620 tau-PET in progressive supranuclear palsy. [2022]
Preclinical Safety Evaluation and Human Dosimetry of [18F]MK-6240, a Novel PET Tracer for Imaging Neurofibrillary Tangles. [2021]
Clinical evaluation of [18F] JNJ-64326067, a novel candidate PET tracer for the detection of tau pathology in Alzheimer's disease. [2021]