Izaflortaucipir (18F) for Down syndrome|Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Subjects with Down syndrome of both sexes between 40 and 60 years."}
• {"criterion_text":"- With a degree of intellectual disability that allows completing the CAMCOG cognitive battery.mild or moderate."}
• {"criterion_text":"- Diagnosis of Down syndrome confirmed by karyotyping."}
• {"criterion_text":"- Patients with good general health."}

Exclusion criteria

• {"criterion_text":"- Inability to give informed consent."}
• {"criterion_text":"- Any significant unstable medical or psychiatric condition or disease."}
• {"criterion_text":"- Common contraindications for MRI (claustrophobia, pacemaker, aneurysm clip, etc.). aneurysm clip, etc.)."}
• {"criterion_text":"- Pregnancy."}
• {"criterion_text":"- Psychiatric illnesses that may affect cognition, such as bipolar disorder or schizophrenia, or the use of medications or substance abuse."}
• {"criterion_text":"- Current use of sedatives/hypnotics, stimulants, antipsychotics, gabapentin, pregabalin, tricyclic antidepressants and trazodone, or other psychoactive medications that may alter slow wave sleep (SWS) or body temperature"}
• {"criterion_text":"- Gastrointestinal conditions that may present a risk of bowel wall protrusion."}
• {"criterion_text":"- Use of new psychoactive drugs in the three months prior to the study."}
• {"criterion_text":"- Irregular sleep cycles, extremely long or short total sleep duration and extreme unstable circadian mismatch (3 months or more)."}
• {"criterion_text":"- Medical conditions including uncontrolled pulmonary or cardiac disease, untreated hypothyroidism, brain tumors, stroke, head trauma and hydrocephalus. It should be noted that thyroid status will be assessed by TSHs and Free T3 and T4 at the time of medical screening."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region.","definition_or_measurement_approach":"SUVR of images generated with 18F-PI-2620 co-registered with structural MRI using SPM12; cerebellum used as reference region."}
• {"endpoint_text":"- Longitudinal changes in the assessment of neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).","definition_or_measurement_approach":"SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620, assessed longitudinally."}

Secondary endpoints

• {"endpoint_text":"- Correlation of SUVR with longitudinal changes in the assessment of neurofibrillary pathology through Tau tracer neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).","definition_or_measurement_approach":"Correlation analyses between SUVR and longitudinal neurofibrillary pathology measures (SUVR in Braak regions for PI-2620)."}
• {"endpoint_text":"- Correlation of SUVR with clinical variables (CAMDEX-DS, CAMCOG) to be obtained from the neuropsychological evaluations.","definition_or_measurement_approach":"Correlation between SUVR and clinical/neuropsychological scales CAMDEX-DS and CAMCOG."}
• {"endpoint_text":"- Correlation of SUVR with measures of brain atrophy (cortical thickness) as measured by FreeSurfer based on data derived from MRI acquisition.","definition_or_measurement_approach":"Correlation between SUVR and cortical thickness measures obtained from MRI using FreeSurfer."}
• {"endpoint_text":"- Correlation of SUVR with plasma biomarker measurements.","definition_or_measurement_approach":"Correlation analyses between SUVR and plasma biomarker measurements."}

Spain

Earliest CTIS Part Ii Submission Date

12-09-2023

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

588

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain