Study of the positron emission tomography (PET) tracer for tau 18F-PI-2620 in individuals with Down syndrome

Institut de Recerca HSCSP0 sites80 target enrollmentJune 4, 2020

Overview

No summary available.

Registry

who.int

Start Date

June 4, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Institut de Recerca HSCSP

•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.

•\- 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.