ONGITUDINAL STUDY OF THE POSITRON EMISSION TOMOGRAPHY (PET) TRACER FOR TAU 18F-PI-2620 IN INDIVIDUALS WITH DOWN SYNDROME

Phase 1

Conditions: Alzheimer disease, Down Syndrome
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: CTIS2024-515574-27-00

Lead Sponsor: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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 Criteria

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., Severe depression (Geriatric Depression Scale score > 20), History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness., Confirmed pregnancy or possibility of pregnancy at the time of study inclusion.