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Longitudinal multicenter head-to-head harmonization of tau PET tracers (HEAD Study)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510508-31-01
Acronym
IIBSP-HEA-2022-145
Enrollment
150
Registered
2024-06-19
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-12-03

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

Conditions

cognitive impairment

Brief summary

The main outcome variable derived from the administration of the radiopharmaceutical will be the Standardized Uptake Value Ratio (SUVR) from different PET tau images, which will be co-registered with the structural MRI image. The lower cerebellar cortex will be used as a reference region

Detailed description

SUVR values obtained for different tracers., Voxel-wise and regional correlation analysis., Transformed values to standardize tau PET tracers to a common scale., Diagnostic performance among different groups., Associations of tau tracers with amyloid., Associations of tau tracers with brain atrophy., Associations of tau tracers with cognition., Associations of tau tracers with plasma tau biomarkers (p-tau181, p-tau-217, and p-tau231)., Longitudinal tau accumulation rates among tracers., Associations between longitudinal changes in tau and amyloid deposition., Associations between longitudinal changes in tau and brain atrophy., Asociaciones entre los cambios longitudinales en tau y progresión en cognición.

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 64 Years

Design outcomes

Primary

MeasureTime frame
The main outcome variable derived from the administration of the radiopharmaceutical will be the Standardized Uptake Value Ratio (SUVR) from different PET tau images, which will be co-registered with the structural MRI image. The lower cerebellar cortex will be used as a reference region

Secondary

MeasureTime frame
SUVR values obtained for different tracers., Voxel-wise and regional correlation analysis., Transformed values to standardize tau PET tracers to a common scale., Diagnostic performance among different groups., Associations of tau tracers with amyloid., Associations of tau tracers with brain atrophy., Associations of tau tracers with cognition., Associations of tau tracers with plasma tau biomarkers (p-tau181, p-tau-217, and p-tau231)., Longitudinal tau accumulation rates among tracers., Associations between longitudinal changes in tau and amyloid deposition., Associations between longitudinal changes in tau and brain atrophy., Asociaciones entre los cambios longitudinales en tau y progresión en cognición.

Countries

Spain

Outcome results

None listed

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