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

NCT ID: NCT04715750

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2022-10-26

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).

Detailed Description

This is an open-label, single center study to visually assess and quantitatively compare brain PET images obtained after application of [18F]PI-2620 with different specific activities: 1) High specific activity (low mass dose): 185 MBq containing a maximum mass dose of ≤5 μg in up to 10 mL and 2) Low specific activity (high mass dose): 185 MBq containing a maximum mass dose of 40-50 μg in up to 10 mL).

Conditions

Alzheimer Disease; Progressive Supranuclear Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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)

Group Type: EXPERIMENTAL

[18F]-PI2620

Intervention Type: 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).

Interventions

[18F]-PI2620

\[18F\]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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life Molecular Imaging SA

INDUSTRY

Sponsor Role: collaborator

Life Molecular Imaging GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Stephens, MD, PhD

Role: STUDY_DIRECTOR

Life Molecular Imaging GmbH

Locations

Department of Nuclear Medicine, University Hospital Leipzig

Leipzig, , Germany

Countries

Germany

Other Identifiers

LMT-01-01-19

Identifier Type: -

Identifier Source: org_study_id