IZAFLORTAUCIPIR (18F) for Down syndrome|Alzheimer disease

Inclusion criteria

• {"criterion_text":"- Men and women aged > 35 years."}
• {"criterion_text":"- Absence of cognitive complaints."}
• {"criterion_text":"- Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficits (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scaled score of 8 or higher, and a clinical dementia rating (CDR) scale score of 0 (Morris 1993)."}
• {"criterion_text":"- Understanding and acceptance of study procedures and signing an informed consent form (by the guardian and/or patient). Inclusion criteria for participants with DS: 1. Men and women diagnosed with DS > 35 years. 2. Intelligence quotient > 34 (equivalent to mild and moderate intellectual disability according to ICD-10 criteria). 3. Presence of a reliable informant. 4. Participants/legal guardians who sign the informed consent form for inclusion in the study."}

Exclusion criteria

• {"criterion_text":"- The exclusion criteria for all groups will be: 1. Failure to meet the inclusion criteria. 2. Severe depression (Geriatric Depression Scale score > 20). 3. History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness. 4. Confirmed pregnancy or possibility of pregnancy at the time of study inclusion."}
• {"criterion_text":"- Severe depression (Geriatric Depression Scale score > 20)"}
• {"criterion_text":"- History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness."}
• {"criterion_text":"- Confirmed pregnancy or possibility of pregnancy at the time of study inclusion."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy variable of the study, at both measurement time points, will be the Standardized Uptake Value Ratio (SUVR) from images generated with 18F-PI-2620 (images will be obtained between 0-90 minutes post-administration; the cerebellum will be used as the reference region), as a measure of tau protein aggregates in the brain.","definition_or_measurement_approach":"SUVR measured from images generated with 18F-PI-2620 obtained between 0-90 minutes post-administration; cerebellum used as reference region to quantify tau protein aggregates."}
• {"endpoint_text":"- In addition to efficacy data, adverse effects will be recorded during the 24 hours following administration.","definition_or_measurement_approach":"Recording of adverse effects occurring during the 24 hours following administration."}

Spain

Earliest CTIS Part Ii Submission Date

26-06-2024

Latest Decision Or Authorization Date

19-06-2025

Processing Time Days

358

Number Of Sites

1

Number Of Participants

80

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