LONGITUDINAL STUDY OF THE POSITRON EMISSION TOMOGRAPHY (PET) TRACER FOR TAU 18F-PI-2620 IN INDIVIDUALS WITH DOWN SYNDROME
Key facts
- Where
- Barcelona, SpanyolországSee the site
- Phase
- 2. fázis
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Trial code
- EU 2024-515574-27-00
- Record updated
- 2025. június 19.
- Original description
• Obtain information on the efficacy of 18F-PI-2620, measured longitudinally, in detecting tau pathology in AD associated with DS. • Evaluate the safety of 18F-PI-2620 in healthy subjects and subjects with Down syndrome.Read full original descriptionShow less
• Obtain information on the efficacy of 18F-PI-2620, measured longitudinally, in detecting tau pathology in AD associated with DS. • Evaluate the safety of 18F-PI-2620 in healthy subjects and subjects with Down syndrome.
Inclusion: Men and women aged > 35 years; Absence of cognitive complaints; 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); 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: 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; History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness; Severe depression (Geriatric Depression Scale score > 20); Confirmed pregnancy or possibility of pregnancy at the time of study inclusion.