Cholesterol metabolism and biomarker links in neurodegenerative dementias
Official title: In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT07207486 · Data updated 2026-11-12
We will measure cholesterol metabolites in brain tissue, spinal fluid, and blood to see if they relate to disease severity and progression in people with Alzheimer's disease, frontotemporal dementia, and related tauopathies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Torino, to and 1 other locations) |
| Status | Recruiting |
| Started | June 5, 2023 |
| Main results expected | April 29, 2027 |
| Study ends | April 29, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07207486 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 40–85 with a clinical diagnosis of Alzheimer's disease, frontotemporal dementia, PSP/CBD or other primary tauopathies and a Mini-Mental State Examination score greater than 10.
✕Probably not a fit
People under 40, those with severe chronic metabolic, other neurological or psychiatric disorders, very advanced dementia (MMSE ≤10), or cognitive impairment due to non-neurodegenerative causes are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This monocentric, low-intervention project uses both retrospective samples and a prospective longitudinal cohort to study oxysterols and related biomarkers across neurodegenerative dementias. Investigators will analyze post-mortem brain tissue, cerebrospinal fluid, and plasma from patients with AD, FTD, PSP/CBD and age-matched controls and correlate metabolite levels with Aβ deposition, tau pathology, neuronal loss, and clinical measures. The study includes neuropathologically characterized brain samples and retrospective CSF/plasma from defined patient groups, plus newly recruited patients followed over time. Analyses will also explore the relationship between oxysterol changes and PCSK9 expression to clarify cholesterol metabolism's role in disease mechanisms.
Why it matters
Potential benefit: If successful, this work could identify cholesterol-related biomarkers that help predict disease severity and progression and reveal new targets for therapies.
How similar studies have gone: Previous studies have linked high cholesterol, oxysterols, and PCSK9 to Alzheimer's pathology, but measuring oxysterols across brain, CSF, and plasma in several dementia types together is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 40-85 * Diagnosis based on the current diagnostic criteria for AD (McKhann et al., 2011), FTD (Gorno-Tempini et al., 2011; Rascovsky et al., 2011), PSP and CBD (Amstrong et al., 2013; Höglinger et al., 2017) * Mini Mental State Examination MMSE \> 10. Exclusion Criteria: * Other neurological or psychiatric disorders Severe chronic metabolic diseases
Where it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy Recruiting -
Università di Torino AOU San Luigi Gonzaga
Torino, to, Italy Withdrawn
Study contacts
- Study coordinator: Paola Caroppo, MD
- Email: paola.caroppo@istituto-besta.it
- Phone: 02.2394.2260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.