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

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ClinicalTrials.gov Identifier: NCT04715750
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Life Molecular Imaging SA
Information provided by (Responsible Party):
Life Molecular Imaging SA ( Life Molecular Imaging GmbH )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Progressive Supranuclear Palsy Drug: [18F]-PI2620 Phase 1

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open Label, Single Center Study to Evaluate the Safety and Imaging Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Mild to Moderate Alzheimer's Disease (AD) and Patients With Progressive Supranuclear Palsy (PSP) After i.v. Application of [18F]PI-2620 With High and Low Specific Activity
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Drug: [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).


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 4-54 days ]
    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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 4-54 days ]
    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 quantitatively analyzed. Quantitative analysis of the tau signal pattern will be compared for high and low specific activity images within the same subject.

  2. Number of adverse events [ Time Frame: From injection of [18F]PI-2620 until up to 6 days after injection ]
    Safety will be evaluated by collection of Adverse Events.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria for mild-moderate AD patients

  • 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

Inclusion Criteria for patients with probable PSP

  • 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 (for all patients)

  • 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
  • MRI exclusion criteria include: Findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1 cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recovery (FLAIR) sequence that is >=20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with Central Nervous System (CNS) disease
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715750


Contacts
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Contact: Audrey Perrotin, PhD +49 (0)30 461 1246 03 GRA@life-mi.com
Contact: Aleksandar Jovalekic, PhD

Locations
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Germany
Department of Nuclear Medicine, University Hospital Leipzig Recruiting
Leipzig, Germany
Contact: Franziska Zientek         
Principal Investigator: Osama Sabri, MD, PhD         
Sponsors and Collaborators
Life Molecular Imaging GmbH
Life Molecular Imaging SA
Investigators
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Study Director: Andrew Stephens, MD, PhD Life Molecular Imaging GmbH
More Information
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Responsible Party: Life Molecular Imaging GmbH
ClinicalTrials.gov Identifier: NCT04715750    
Other Study ID Numbers: LMT-01-01-19
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Life Molecular Imaging SA ( Life Molecular Imaging GmbH ):
Tau PET
[18F]PI-2620
Mass dose
 Specific activity
Alzheimer Disease
Progressive Supranuclear Palsy
Additional relevant MeSH terms:
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Alzheimer Disease
Supranuclear Palsy, Progressive
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Paralysis
Neurologic Manifestations
Basal Ganglia Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases