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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515574-27-00
Acronym
IIBSP-FPI-2019-108
Enrollment
80
Registered
2024-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Alzheimer disease

Brief summary

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., In addition to efficacy data, adverse effects will be recorded during the 24 hours following administration.

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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., In addition to efficacy data, adverse effects will be recorded during the 24 hours following administration.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026