Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity

NCT04715750 | Completed Phase 1 DMC

• 1 other identifier: LMT-01-01-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).

Conditions

Alzheimer Disease; Progressive Supranuclear Palsy

Keywords

Tau PET; [18F]PI-2620; Mass dose; Specific activity; Alzheimer Disease; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Comparability of visual assessment of PI-2620 tau PET images obtained after injection of high specific activity and low specific activity in AD and PSP patients.

  PI-2620 tau PET images obtained with \[18F\]PI-2620 using high specific activity (185 MBq and ≤ 5 µg mass dose) and with \[18F\]PI-2620 using low specific activity (185 MBq and 40-50 µg mass dose) in AD and PSP patients will be visually analyzed. Visual analysis of the tau signal pattern will be compared for high and low specific activity images within the same subject.

  4-54 days

Secondary Outcomes (2)

• Comparability of quantitative assessment of PI-2620 tau PET images obtained after injection of high specific activity and low specific activity in AD and PSP patients.

  4-54 days

• Number of adverse events

  From injection of [18F]PI-2620 until up to 6 days after injection

Study Arms (1)

Tau deposition in the brains of Alzheimer Disease and Progressive Supranuclear Palsy patients

EXPERIMENTAL

All patients will receive two administrations of \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose)

Drug: [18F]-PI2620

Interventions

[18F]-PI2620 DRUG

\[18F\]PI-2620 is a radioactive diagnostic agent being developed for the indication of PET imaging of the brain to detect tau pathology in adult patients who are being evaluated for neurodegenerative decline. All patients will receive two administrations of \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).

Tau deposition in the brains of Alzheimer Disease and Progressive Supranuclear Palsy patients

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 50-80 years
• Able to understand, sign and date written informed consent, which is confirmed by the judgment of the referring physician
• Written informed consent must be obtained before any assessment is performed
• Prior evaluable MRI
• Female patients must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, must commit to use of a highly effective contraceptive measure for the duration of the study
• Male patients and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of one week following each PET scan
• Male patients must commit to not donate sperm for a minimum of one week after each PET scan.
• Patients with mild or moderate AD in accordance with NIA-AA guidelines 2011
• Have a CDR score of ≥ 0.5 at screening
• Have an MMSE score of ≤ 24 at screening
• Prior evaluable amyloid PET imaging confirming presence of beta-amyloid brain pathology
• Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the \[18F\]PI-2620 PET imaging visits
• Patients with a clinical diagnosis of probable PSP based on the Movement Disorder Society criteria (Höglinger et al., 2017).
• Have a PSP rating score between 20 - 60
• Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before the \[18F\]PI-2620 PET imaging visits

You may not qualify if:

• Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2
• Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the study procedures
• Patient has received an investigational drug including treatments targeting amyloid-beta plaques or tau within 3 months of screening
• Pregnant (or intention of getting pregnant), lactating or breastfeeding
• Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI
• Unwilling and/or unable to cooperate with study procedures

Sponsors & Collaborators

• Life Molecular Imaging GmbH: lead
• Life Molecular Imaging SA: collaborator

Study Sites (1)

Department of Nuclear Medicine, University Hospital Leipzig

Leipzig, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease; Supranuclear Palsy, Progressive

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Basal Ganglia Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Stephens, MD, PhD

  Life Molecular Imaging GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 20, 2021
• Study Start: November 12, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)