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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508718-40-00 | EU Trial (CTIS) Number |
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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.
Phase II, uncontrolled, single-center, uncontrolled, drug-controlled clinical trial for the evaluation of a diagnostic test (PI-2620).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suggestive of progressive supranuclear paralysis | Active Comparator | Patients will receive the radiotracer |
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| Patients with probable progressive supranuclear palsy | Active Comparator | Patients will receive the radiotracer |
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| Control Arm. No pathologies control arm | Active Comparator | Patients will receive the radiotracer |
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| Control arm. Patients with parkinson | Active Comparator | Patients will receive the radiotracer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotracer | Combination Product | Patients will receive a brain tau radiotracer |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day Zero Visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Standard optic value ratio(SUVR) from basic core | Ratio of captation compare with healthy captation(ratio) | Day Zero Visit 1 |
| Standard optic value ratio(SUVR) from cerebral cortex | Ratio of captation in compare of a healthy captation |
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Inclusion Criteria:
For all patients:
For PSP patients:
For Parkinson patients:
For control patients:
- Absence of clinical history of neuropsychiatric disease.
Exclusion Criteria:
For all patients:
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).
with PI-2620.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Burunat | Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Day Zero Visit 1 |
| PI-2620 Captation in compare to demographics as age | PI-2620 captation in relation to age(Captation vs patient age) | Day Zero Visit 1 |
| PI-2620 Captation in compare to demographics as gender | PI-2620 captation in compare to gender(captation vs male/female) | Day Zero Visit 1 |
| PI-2620 Captation in compare to demographics as reference Hospital | PI-2620 captation vs reference Hospital | Day Zero Visit 1 |
| PI-2620 Captation in compare to clinics as PSPRS scale | It measures the severity associated with Parkinson's disease(range) | Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit) |
| PI-2620 Captation in compare to clinics as PSP-CDS | It measures the severity associated with Parkinson's disease(range) | Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit) |
| 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) | Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit) |
| 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) | Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit) |
| 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) | Visit zero, selection visit and last visit(18month visit) |
| 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) | Visit zero, selection visit and last visit(18month visit) |
| 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) | Visit zero, selection visit and last visit(18month visit) |
| 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) | Visit zero, selection visit and last visit(18month visit) |
| PI-2620 administration and Patient safety | All the adverse events occurred along the patient participation will be registred(medRA code) | Day zero(Visit1), day 7(V2), six month(Visit 3), 12 month(V4), and final visit(18 month) |
| 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). | Month 6 (Visit 3) |
| Liver function tests | Blood test where GOT, GGT, GPT, AST, ALT, LDH and Albumin will be tested(g/dL) | Day zero(Visit 1) and 6 month(Visit 3) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |