Taupathies
Conditions
Interventions
Product Name: 18F-PI-2620
Product Code: 18F-PI-2620
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: 18F-PI-2620
Current Sponsor code: 18F-PI-2620
Other descriptive name: (2-(2-
Sponsors
Institut de Recerca HSCSP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria of control subjects: - Men and women with age> 35 years. - Absence of cognitive complaints. - Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficit (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scalar score equal to or greater than 8 and a clinical dementia rating scale (CDR) score of 0 (Morris 1993). - Understand and accept the study procedures and sign an informed consent (guardian and / or patient). Inclusion criteria for participants with DS: - Men and women diagnosed with DS> 35 years. - Intellectual quotient> 34 (equivalent to mild and moderate mental retardation according to ICD-10 criteria). - Existence of reliable informant. - Participants / legal guardians who sign the IC for inclusion in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Not meeting the inclusion criteria. - Severe depression (Geriatric scale score Scale depression> 20). - History of stroke, Hachinski score> 4 or previous neurological or psychiatric illness. - Confirmed pregnancy or possibility of pregnancy at the time of inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To obtain preliminary information on the efficacy of 18F-PI-2620 in the detection of tau pathology in AD associated with SD - To evaluate the safety of 18F-PI-2620 in healthy subjects, subjects with SD.;Secondary Objective: To correlate the uptake of 18F-PI-2620 with: - Cognitive and functional scales. - Measures of cerebral atrophy in MRI. - Tau and phosphorylated tau levels in the cerebrospinal fluid.;Primary end point(s): - Standardized uptake value ratio (SUVR) of images generated with 18F-PI-2620 (images measured between 0-90 min of administration will be obtained; SUVR images of 18F-PI-2620 will be corrected to the RM using the software SPM8. The cerebellum will be used as the reference region), as a measure of tau protein aggregates in the brain. - Presence of adverse effects within 24 hours after administration.;Timepoint(s) of evaluation of this end point: 90 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Correlation of SUVR with the clinical variables (CAMDEX-DS, CAMCOG) that will be obtained from the patient's medical history. - Correlation with measures of cerebral atrophy measured by FreeSurfer in MR (cortical thickness). - Correlation with the measures of tau and phosphorylated tau in CSF.;Timepoint(s) of evaluation of this end point: 90 minutes | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca HSCSP
Outcome results
None listed