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Parkinson DiseasePhase 2Quanti-TAU-PETNCT07105384

Quantification Tools for a Novel Tau PET Marker in a Rare Neurological Disease: 18F-PI-2620 in Progressive Supranuclear Palsy

A Phase 2 study testing Radiotracer in people with Parkinson Disease, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of progressive supranuclear palsy (PSP), an atypical form of parkinsonism. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
Radiotracer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSpain
Study dates
4 Feb 2025to 20 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For all patients:
  • Patients of both sexes between 40 and 80 years of age.
  • The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
  • Conformity of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent form.
  • In women, postmenopausal status (one year without menstruation without other medical causes) or negative pregnancy test. Subjects (women and partners of male of childbearing age must accept the commitment to practice sexual abstinence or use highly effective contraceptive methods (hormonal contraceptives that inhibit ovulation, IUD, surgical sterilization) from their inclusion in the study up to one month after the PET scan.
  • For PSP patients:
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  • Have a clinical diagnosis of probable soPSP or PSP according to current diagnostic criteria (Höglinger et al. current diagnostic criteria (Höglinger et al. 2017).
  • Magnetic resonance imaging (MRI) study that rules out any other relevant neurological pathology. relevant neurological pathology.
  • For Parkinson patients:
  • To have a clinical diagnosis of Parkinson's disease according to established criteria (Postuma et al. 2015).
  • Magnetic resonance imaging (MRI) study that rules out any other relevant neurological pathology.
  • For control patients:
  • Absence of clinical history of neuropsychiatric disease.

Who cannot join

  • For all patients:
  • Diagnosis of relevant central nervous system disease such as:
  • Huntington's disease, normotensive hydrocephalus, cerebrovascular disease, frontotemporal dementia, Alzheimer's disease, history of major or recurrent traumatic brain injury, history of epilepsy or seizures history of major or recurrent traumatic brain injury, history of epilepsy or seizures(except febrile seizures in childhood without current antiepileptic medication).
  • Presence of terminal illness or illnesses that may put the patient's health at risk by participating in the the patient's health by participating in the study or influencing the results of the study or the patient's or on the patient's ability to participate in the study.
  • Abuse of alcohol or other legal or illegal drugs (except nicotine).
  • Pregnancy.
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  • Known allergy to PI-2620 or any of the other components of the radiopharmaceutical.
  • Any contraindication or impediment to the performance of the PET/CT study with PI-2620.
  • with PI-2620.
  • Subjects who are not capable of understanding and/or complying with the guidelines necessary for the performance of the test (e.g.: interrogation, physical examination, attending the lumbar puncture, attending the visits, etc.) and who do not have responsible accompanying persons who understand and are committed to complying with these guidelines.
  • Subjects who do not cooperate or are not capable of complying with the required procedures required for this clinical trial, such as (but not limited to): social disorders that anticipate an evident lack of collaboration, psychopathy, drug or alcohol abuse.
  • Subjects or their legal representatives who do not sign the informed consent.
  • Legal incapacity and/or circumstances that prevent the subject or his/her legal representatives from understanding the nature, objectives, potential and possible consequences of the trial.
  • Treatment with any other investigational drug in the 30 days prior to inclusion.
  • For PSP patients:
  • Diagnosis or suspicion of any parkinsonian syndrome other than PSP such as idiopathic Parkinson's disease, pharmacological parkinsonism, essential tremor, primary dystonias or any other cause that may produce symptoms similar to those of Parkinson's disease.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Laura Burunat

    Barcelona, Barcelona, 08036

Other trials in Spain

About this study

The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of progressive supranuclear palsy (PSP), an atypical form of parkinsonism.

Read the detailed description

Phase II, uncontrolled, single-center, uncontrolled, drug-controlled clinical trial for the evaluation of a diagnostic test (PI-2620).

Being tested
Radiotracer
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotracerCombination product

    Patients will receive a brain tau radiotracer

Study groups in NCT07105384
Study groupRoleWhat they receive
Patients suggestive of progressive supranuclear paralysisActive comparatorPatients will receive the radiotracer
Receives: Combination Product: Radiotracer
Patients with probable progressive supranuclear palsyActive comparatorPatients will receive the radiotracer
Receives: Combination Product: Radiotracer
Control Arm. No pathologies control armActive comparatorPatients will receive the radiotracer
Receives: Combination Product: Radiotracer
Control arm. Patients with parkinsonActive comparatorPatients will receive the radiotracer
Receives: Combination Product: Radiotracer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in uptake levels of PET-PI-2620, a brain tau radiotracer, in participants with a diagnosis suggestive of PSP, probable PSP, Parkinson's and controls without neurological pathology.

    The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of progressive supranuclear palsy (PSP), an atypical form of parkinsonism( Molecular imaging)

    Measured: Day Zero Visit 1

Secondary outcomes (16)

  1. Standard optic value ratio(SUVR) from basic core

    Ratio of captation compare with healthy captation(ratio)

    Measured: Day Zero Visit 1

  2. Standard optic value ratio(SUVR) from cerebral cortex

    Ratio of captation in compare of a healthy captation

    Measured: Day Zero Visit 1

  3. PI-2620 Captation in compare to demographics as age

    PI-2620 captation in relation to age(Captation vs patient age)

    Measured: Day Zero Visit 1

  4. PI-2620 Captation in compare to demographics as gender

    PI-2620 captation in compare to gender(captation vs male/female)

    Measured: Day Zero Visit 1

  5. PI-2620 Captation in compare to demographics as reference Hospital

    PI-2620 captation vs reference Hospital

    Measured: Day Zero Visit 1

  6. PI-2620 Captation in compare to clinics as PSPRS scale

    It measures the severity associated with Parkinson's disease(range)

    Measured: Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit)

  7. PI-2620 Captation in compare to clinics as PSP-CDS

    It measures the severity associated with Parkinson's disease(range)

    Measured: Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit)

  8. PI-2620 Captation in compare to clinics as Hoen & Yahr classification

    Disability associated with Parkinson's disease. It helps in describing the progression of the disease(range)

    Measured: Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit)

  9. PI-2620 Captation in compare to clinics as Schwab & England daily living activites scale scale

    Is a method of assessing the capabilities of people with impaired mobility(percentage)

    Measured: Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit)

  10. PI-2620 Captation in compare to clinics as Cerebrospinal fluid biomarkers: NfL(neurofilament light chain)

    CSF biomarkers have been found to have the highest diagnostic potential(pg/mL)

    Measured: Visit zero, selection visit and last visit(18month visit)

  11. PI-2620 Captation in compare to clinics as Cerebrospinal fluid biomarkers: Amyloid beta

    CSF biomarkers have been found to have the highest diagnostic potential(pg/mL)

    Measured: Visit zero, selection visit and last visit(18month visit)

  12. PI-2620 Captation in compare to clinics as Cerebrospinal fluid biomarkers: tau & 4R-tau

    CSF biomarkers have been found to have the highest diagnostic potential(pg/mL)

    Measured: Visit zero, selection visit and last visit(18month visit)

  13. PI-2620 Captation in compare to clinics as Cerebrospinal fluid biomarkers: Alfa sinucleyna

    CSF biomarkers have been found to have the highest diagnostic potential(pg/mL)

    Measured: Visit zero, selection visit and last visit(18month visit)

  14. PI-2620 administration and Patient safety

    All the adverse events occurred along the patient participation will be registred(medRA code)

    Measured: Day zero(Visit1), day 7(V2), six month(Visit 3), 12 month(V4), and final visit(18 month)

  15. Ophthalmological examination

    Ophthalmological examination. A standard of care review will be done in order to find abnormalities which may or not had appeared since inclusion. It is a security decission.(Descrption of the abnormality if applies).

    Measured: Month 6 (Visit 3)

  16. Liver function tests

    Blood test where GOT, GGT, GPT, AST, ALT, LDH and Albumin will be tested(g/dL)

    Measured: Day zero(Visit 1) and 6 month(Visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start4 Feb 2025
  3. Primary completion20 Jun 2028 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

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 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105384
Sponsor's protocol ID
2023-508718-40-00
Other IDs
2023-508718-40-00, 2023
Acronym
Quanti-TAU-PET
Status last verified
Mar 2025
First submitted
27 Mar 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotracer in people with Parkinson Disease, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

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 13 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Differences in uptake levels of PET-PI-2620, a brain tau radiotracer, in participants with a diagnosis suggestive of PSP, probable PSP, Parkinson's and controls without neurological pathology. (time frame: Day Zero Visit 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07105384.

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 5 Aug 2025.

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