Biomarkers for Monitoring Dementia Progression

NCT06855368 | Recruiting

• 1 other identifier: RP 22/25
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype.

Conditions

Alzheimer Disease

Keywords

EEG; functional connectivity; neuroinflammation; nanoparticles

Outcome Measures

Primary Outcomes (7)

• Identification of Disease-Associated Phenotypes in MCI and AD

  through study completion, an average of 1 year

• Identification of Disease-Associated Early Interventions in MCI and AD

  through study completion, an average of 1 year

• Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion

  EEG power spectral density

  through study completion, an average of 1 year

• Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation

  through study completion, an average of 1 year

• Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation

  through study completion, an average of 1 year

• Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages

  through study completion, an average of 1 year

• Assessment of Activated Leukosomes in Glial Cells

  through study completion, an average of 1 year

Study Arms (3)

AD

MCI

HC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 AD and 100 MCI individuals from the dementia clinical centres of North Sardinia and local sections of patients¿ associations and 100 HC will be recruited for the study. To investigate past/present health status and medications, baseline medical screening will be performed by general clinical and anthropometric examinations

You may qualify if:

• mild AD and patients with mild cognitive impairment (MCI).

You may not qualify if:

• major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness
• any medical or drug-related condition affecting cognitive or mood status
• history or current alcohol/illicit drug abuse.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (2)

IRCCS San Raffaele

Roma, 00163, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliero-Universitaria di Sassari

Sassari, 07100, Italy

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lucia Gatta, PhD

CONTACT

+390652253440; lucia.gatta@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: March 3, 2025
• Study Start: May 18, 2023
• Primary Completion: May 17, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

IT (2)