In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias
Study on Cholesterol's Role in Dementia Progression
Plain English Summary
In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias is a Not Applicable clinical trial sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta studying Dementias, Neurodegenerative Dementia. This study investigates how cholesterol and its byproducts affect the development and worsening of neurodegenerative dementias like Alzheimer's. It is for individuals diagnosed with specific types of dementia, aged 40-85, who have a certain level of cognitive function. Participation involves providing biological samples (like blood and spinal fluid) and potentially brain tissue after death for analysis. Currently, there are no direct alternative treatments being tested in this observational study; standard care for dementia would be the alternative. The trial aims to enroll 80 participants.
Official 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
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 40 and 85 years old and have a confirmed diagnosis of Alzheimer's disease, frontotemporal dementia, progressive supranuclear palsy, or corticobasal degeneration. You must have a Mini Mental State Examination (MMSE) score greater than 10, indicating a certain level of cognitive ability. You cannot join if you have other serious brain or mental health conditions, or severe long-term metabolic diseases. This trial is studying Dementias, Neurodegenerative Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how cholesterol building blocks differ over 12 months, helping researchers understand if these changes are linked to how the disease progresses. The specific primary outcome measures are: Characterize differences in cholesterol precursors (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it seeks to understand how cholesterol metabolism might be a common factor in various neurodegenerative dementias, potentially leading to new ways to diagnose or treat This research targets Dementias, Neurodegenerative Dementia, where improved treatment options are needed.
Investor Insight
This observational study aims to uncover fundamental biological mechanisms, which could inform future drug development for a large market of dementia patients, though direct approval probability is no
Is This Trial Right for Me?
Ask your doctor about the specific types of dementia included and what your participation would entail. Be prepared for potential sample collection (blood, spinal fluid) and understand the long-term nature of the study. Discuss any concerns about privacy and how your data will be used. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 80 participants
Primary Outcomes
- Characterize differences in cholesterol precursors (12 months)
Secondary Outcomes
- different brain areas (12 months)
- cerebral oxysterol changes in AD (12 months)
- different cholesterol precursors in neurodegenerative diseases examined in CSF and plasma (12 months)
- cortical atrophy (12 months)
- PCSK9 (12 months)
Full Eligibility 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
Trial Locations
- Università di Torino AOU San Luigi Gonzaga, Torino, to, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
Frequently Asked Questions
What is clinical trial NCT07207486?
NCT07207486 is a Not Applicable OBSERVATIONAL study titled "In-depth Analysis of Cholesterol Metabolism and Related Biomarkers in the Pathogenesis and Progression of the Disease in Neurodegenerative Dementias." It is currently recruiting and is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial targets enrollment of 80 participants.
What conditions does NCT07207486 study?
This trial investigates treatments for Dementias, Neurodegenerative Dementia. The primary condition under study is Dementias.
What does Not Applicable mean for NCT07207486?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07207486?
This trial is currently "Recruiting." It started on 2023-06-05. The estimated completion date is 2027-04-29.
Who is sponsoring NCT07207486?
NCT07207486 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07207486?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT07207486 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07207486?
The primary outcome measures are: Characterize differences in cholesterol precursors (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07207486 being conducted?
This trial is being conducted at 2 sites, including Torino, to; Milan (Italy).
Where can I find official information about NCT07207486?
The official record for NCT07207486 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07207486. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07207486 testing in simple terms?
This study investigates how cholesterol and its byproducts affect the development and worsening of neurodegenerative dementias like Alzheimer's. It is for individuals diagnosed with specific types of dementia, aged 40-85, who have a certain level of cognitive function.
Why is this trial significant?
This trial is important because it seeks to understand how cholesterol metabolism might be a common factor in various neurodegenerative dementias, potentially leading to new ways to diagnose or treat
What are the potential risks of participating in NCT07207486?
As this is an observational study, the primary risks are related to the procedures for sample collection, such as discomfort or bruising from blood draws, or potential headaches from spinal fluid collection. There are no direct treatment risks as participants are not receiving experimental therapies. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07207486?
Ask your doctor about the specific types of dementia included and what your participation would entail. Be prepared for potential sample collection (blood, spinal fluid) and understand the long-term nature of the study. Discuss any concerns about privacy and how your data will be used. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07207486 signal from an investment perspective?
This observational study aims to uncover fundamental biological mechanisms, which could inform future drug development for a large market of dementia patients, though direct approval probability is no This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing biological samples (like blood and spinal fluid) and potentially brain tissue after death for analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Dementias Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.