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

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Brief Title

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

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

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).
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 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.

Condition

Alzheimer Disease

Intervention

[18F]-PI2620

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

November 12, 2020

Completion Date

June 2022

Primary Completion Date

June 2022

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.

        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
      

Gender

All

Ages

50 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Andrew Stephens, MD, PhD, +49 (0)30 461 1246 03, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04715750

Organization ID

LMT-01-01-19


Responsible Party

Sponsor

Study Sponsor

Life Molecular Imaging GmbH

Collaborators

 Life Molecular Imaging SA

Study Sponsor

Andrew Stephens, MD, PhD, Study Director, Life Molecular Imaging GmbH


Verification Date

October 2021