Clinical Trial

In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias

Study acronym: RF-2021-123742
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Summary
The aim of the study is to evaluate the role of cholesterol in the pathogenesis of neurodegenerative dementias. Hypercholesterolemia is a known risk factor for Alzheimer disease (AD), and oxysterols, the principal cholesterol metabolites, are involved in neuroinflammation, amyloid aggregation, and tau accumulation. Oxysterols will be measured in different biological samples (post-mortem brain tissue, CSF, and plasma) from patients with different neurodegenerative dementias, including AD, frontotemporal dementia (FTD), and primary tauopathies. This approach will allow determination of whether their modifications correlate primarily with Aß deposition, tauopathy, or neuronal loss, with the goal of identifying correlations with disease severity and progression. Since preliminary results suggest that the levels of most oxysterols in the brain significantly increase in parallel with the levels of the enzyme PCSK9, the investigators will explore the role of cholesterol metabolism and PCSK9 in AD and other dementias to evaluate whether cholesterol dysregulation represents a common alteration across these neurodegenerative disorders or is specific to AD
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-26.
Trial Details
NCT Number NCT07207486
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: Università di Torino, Torino, Ospedale San Luigi Gonzaga, Orbassano
Conditions Dementias, Neurodegenerative Dementia
Enrollment 80 participants
Start Date 2023-06-05
Primary Completion 2027-04-29 (estimated)
Study Completion 2027-04-29 (estimated)
Updated on ClinicalTrials.gov 2026-02-11