Progressive Supranuclear PalsyPhase 1NCT05187546
Test-retest Study With [18F]PI-2620 in PSP-RS and NDC
A Phase 1 study testing [18F]-PI2620 in people with Progressive Supranuclear Palsy, run by Life Molecular Imaging GmbH at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- [18F]-PI2620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 10 Mar 2022to 5 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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)
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
Read the 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).
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- [18F]-PI2620
- Keywords
- Tau PET, [18F]PI-2620, Test-retest, Progressive Supranuclear Palsy
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-PI2620Drug
[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).
| Study group | Role | What they receive |
|---|---|---|
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients | Experimental | 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. Receives: Drug: [18F]-PI2620 |
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects | Experimental | 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. Receives: Drug: [18F]-PI2620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls
Test-retest variability of [18F]PI-2620 accumulation will be analyzed using quantification
Measured: The duration of the study for participants may be up to 74 days
Number of adverse events
Safety will be evaluated by collection of Adverse Events.
Measured: The duration of the study for participants may be up to 74 days
Secondary outcomes (2)
Compare quantification in terms if test-retest variability in PSP-RS and NDC
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.
Measured: The duration of the study for participants may be up to 74 days
Correlate radioligand binding in PSP-RS with clinical scales
Correlation of radioligand binding with clinical scales in PSP-RS will be analyzed
Measured: The duration of the study for participants may be up to 74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Mar 2022
- Primary completion29 Feb 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Molecular Imaging GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Stephens, MD, PhD, Study director, Lantheus Germany GmbHMatthias Brendel, MD, Principal investigator, Department of Nuclear Medicine, University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187546
- Sponsor's protocol ID
- LMT-02-01-21
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05187546
- Acronym / sponsor ID
- LMT-02-01-21
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Tau PET, [18F]PI-2620, Test-retest, Progressive Supranuclear Palsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Life Molecular Imaging GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients | Experimental | Drug: [18F]-PI2620All 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. |
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects | Experimental | Drug: [18F]-PI2620All 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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 megabecquerel (MBq). | Drug | Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects, Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients |
Primary outcome
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
Test-retest variability of [18F]PI-2620 accumulation will be analyzed using quantification
Number of adverse events
Time frame: The duration of the study for participants may be up to 74 days
Safety will be evaluated by collection of Adverse Events.
2 secondary outcomes
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
Correlate radioligand binding in PSP-RS with clinical scales
Time frame: The duration of the study for participants may be up to 74 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Stephens, MD, PhD study director
Lantheus Germany GmbH
Matthias Brendel, MD principal investigator
Department of Nuclear Medicine, University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]-PI2620 in people with Progressive Supranuclear Palsy, run by Life Molecular Imaging GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.