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Sleep and Temperature Disturbance as risk factors for Alzheimer's Disease in Down Syndrome: a Longitudinal Study.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506609-21-00
Acronym
IIBSP-DOW-2022-150
Enrollment
60
Registered
2024-01-15
Start date
2024-04-09
Completion date
Unknown
Last updated
2025-04-22

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

Conditions

Down Syndrome., Alzheimer´s Disease.

Brief summary

The primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region., Longitudinal changes in the assessment of neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).

Detailed description

Correlation of SUVR with longitudinal changes in the assessment of neurofibrillary pathology through Tau tracer neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620)., Correlation of SUVR with clinical variables (CAMDEX-DS, CAMCOG) to be obtained from the neuropsychological evaluations., Correlation of SUVR with measures of brain atrophy (cortical thickness) as measured by FreeSurfer based on data derived from MRI acquisition., Correlation of SUVR with plasma biomarker measurements.

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 primary endpoint derived from radiopharmaceutical administration of the radiopharmaceutical will be the Standardized uptake value ratio (SUVR) of the images generated with 18F-PI- 2620, which will be co-registered with the structural magnetic resonance magnetic resonance imaging (MRI) using SPM12 software. The cerebellum will be used as the reference region., Longitudinal changes in the assessment of neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620).

Secondary

MeasureTime frame
Correlation of SUVR with longitudinal changes in the assessment of neurofibrillary pathology through Tau tracer neurofibrillary pathology through the Tau tracer (SUVR in Braak regions as defined by Berkeley regions of interest for PI-2620). by Berkeley regions of interest for PI-2620)., Correlation of SUVR with clinical variables (CAMDEX-DS, CAMCOG) to be obtained from the neuropsychological evaluations., Correlation of SUVR with measures of brain atrophy (cortical thickness) as measured by FreeSurfer based on data derived from MRI acquisition., Correlation of SUVR with plasma biomarker measurements.

Countries

Spain

Outcome results

None listed

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