Cholesterol metabolism and biomarker links in neurodegenerative dementias
In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Torino, to and 1 other locations) |
| Trial ID | NCT07207486 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Torino, to and 1 other locations
- Università di Torino AOU San Luigi Gonzaga — Torino, to, Italy (Withdrawn)
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Caroppo, MD
- Email: paola.caroppo@istituto-besta.it
- Phone: 02.2394.2260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.