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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
66
Patients will receive a brain tau radiotracer
Laura Burunat
Barcelona, Barcelona, Spain
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)
Time frame: Day Zero Visit 1
Standard optic value ratio(SUVR) from basic core
Ratio of captation compare with healthy captation(ratio)
Time frame: Day Zero Visit 1
Standard optic value ratio(SUVR) from cerebral cortex
Ratio of captation in compare of a healthy captation
Time frame: Day Zero Visit 1
PI-2620 Captation in compare to demographics as age
PI-2620 captation in relation to age(Captation vs patient age)
Time frame: Day Zero Visit 1
PI-2620 Captation in compare to demographics as gender
PI-2620 captation in compare to gender(captation vs male/female)
Time frame: Day Zero Visit 1
PI-2620 Captation in compare to demographics as reference Hospital
PI-2620 captation vs reference Hospital
Time frame: Day Zero Visit 1
PI-2620 Captation in compare to clinics as PSPRS scale
It measures the severity associated with Parkinson's disease(range)
Time frame: Day Zero Visit 1, month 6(V2), month12(V3) and month 18(final visit)
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PI-2620 Captation in compare to clinics as PSP-CDS
It measures the severity associated with Parkinson's disease(range)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Month 6 (Visit 3)
Liver function tests
Blood test where GOT, GGT, GPT, AST, ALT, LDH and Albumin will be tested(g/dL)
Time frame: Day zero(Visit 1) and 6 month(Visit 3)