Test-retest Study With [18F]PI-2620 in PSP-RS and NDC

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Brief Title

Test-retest Study With [18F]PI-2620 in PSP-RS and NDC

Official Title

An Open Label, Single Center Study to Evaluate the Safety and Test-retest Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS) Compared to Non-demented Controls (NDC)

Brief Summary

      The overall goal of this protocol is to evaluate the imaging characteristics of [18F]PI-2620
      using positron emission tomography (PET) in patients with progressive supranuclear palsy,
      Richardson's syndrome (PSP-RS)
    

Detailed Description

      The imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in
      patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS) will be
      evaluated by a) determining the test-retest variability of the [18F]PI-2620 binding
      parameters in brain of patients with PSP-RS and non-demented controls (NDC).
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls

Secondary Outcome

 Compare quantification in terms if test-retest variability in PSP-RS and NDC

Condition

Progressive Supranuclear Palsy

Intervention

[18F]-PI2620

Study Arms / Comparison Groups

 Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients
Description:  All eligible PSP patients will receive two injections of the investigational imaging agent [18F]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm.

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

15

Start Date

March 10, 2022

Completion Date

December 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria (for all subjects)

          -  Males and females aged 50-80 years

          -  Able to understand, sign and date written informed consent

          -  Signed and dated written informed consent obtained from the subject

          -  The subject has an appropriate caregiver capable of accompanying subject, if necessary

          -  Have an Montreal Cognitive Assessment (MoCa) score ≥ 27

          -  Female subjects 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 subjects and their partners of childbearing potential must commit to the use of a
             highly effective method of contraception for a minimum of 90 days following each PET
             scan

          -  Male subjects must commit to not donate sperm for a minimum of 90 days after each PET
             scan

          -  Willing and able to cooperate with study procedures including lying flat and still on
             the scanning bed for 60 minutes

        Inclusion criteria for non-demented controls (NDC)

          -  Healthy with no clinically relevant finding on physical examination at screening

          -  No cognitive impairment from neuropsychological battery as judged by the investigator

          -  A brain MRI without evidence of significant neurological pathology

          -  A beta-amyloid Neuraceq® PET demonstrating a negative beta-amyloid status

          -  No signs of movement disorder as judged by Progressive Supranuclear Palsy Rating Scale
             (PSPRS), Movement Disorder Society - Unified Parkinson's Disability Rating Scale
             (MDS-UPDRS) and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)

        Inclusion Criteria for patients with probable PSP-RS

          -  Patients with a clinical diagnosis of probable PSP-RS based on the Movement Disorder
             Society criteria (Höglinger et al., 2017)

          -  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 subjects)

          -  Hemoglobin value < 10 g/dL

          -  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

          -  Subjects with clinically significant renal and hepatic dysfunction as judged by the
             investigator

          -  Known hypersensitivity to the active substance or to any of the excipients of
             [18F]PI-2620

          -  Known hypersensitivity to the active substance or to any of the excipients of
             Neuraceq®, for NDC only

          -  Subject has received an investigational drug including treatments targeting
             Amyloid-beta or tau within 3 months of screening

          -  Pregnant (or having the intention of getting pregnant), lactating or breastfeeding

          -  Unsuitable veins for repeated venipuncture.

          -  Subject has a contraindication to blood sampling and/or arterial cannulation,
             including but not limited to peripheral vascular disease, Raynaud's phenomenon as
             determined by abnormal Allen's test or abnormal coagulation profile at screening

          -  MRI exclusion criteria include but not limited to: 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

Accepts Healthy Volunteers

Contacts

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

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT05187546

Organization ID

LMT-02-01-21


Responsible Party

Sponsor

Study Sponsor

Life Molecular Imaging GmbH


Study Sponsor

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


Verification Date

April 2022