- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187546
Test-retest Study With [18F]PI-2620 in PSP-RS and NDC
July 25, 2023 updated by: Life Molecular Imaging GmbH
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)
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Audrey Perrotin, PhD
- Phone Number: +49 (0)30 461 1246 03
- Email: GRA@life-mi.com
Study Contact Backup
- Name: Aleksandar Jovalekic, PhD
- Phone Number: +49 (0)30 461 1246 03
- Email: GRA@life-mi.com
Study Locations
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Munich, Germany, 81377
- Recruiting
- Ludwig-Maximilians-Universität München
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Contact:
- Matthias Brendel, MD
- Phone Number: +4989440074646
- Email: Matthias.Brendel@med.uni-muenchen.de
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients
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.
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[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 megabecquerel (MBq).
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Experimental: Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects
All eligible non-demented control (NDC) subjects 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.
5 NDC subjects will be required to complete the study arm.
|
[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 megabecquerel (MBq).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls
Time Frame: The duration of the study for participants may be up to 74 days
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Test-retest variability of [18F]PI-2620 accumulation will be analyzed using quantification
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The duration of the study for participants may be up to 74 days
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Number of adverse events
Time Frame: The duration of the study for participants may be up to 74 days
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Safety will be evaluated by collection of Adverse Events.
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The duration of the study for participants may be up to 74 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare quantification in terms if test-retest variability in PSP-RS and NDC
Time Frame: The duration of the study for participants may be up to 74 days
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Comparison of quantification in terms of test-retest variability in PSP and NDC.
The ability of [18F]PI-2620 to discriminate between PSP-RS and NDC will be assessed.
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The duration of the study for participants may be up to 74 days
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Correlate radioligand binding in PSP-RS with clinical scales
Time Frame: The duration of the study for participants may be up to 74 days
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Correlation of radioligand binding with clinical scales in PSP-RS will be analyzed
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The duration of the study for participants may be up to 74 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Andrew Stephens, MD, PhD, Life Molecular Imaging
- Principal Investigator: Matthias Brendel, MD, Department of Nuclear Medicine, University of Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2022
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMT-02-01-21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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