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NCT Number: NCT06855368

Biomarkers for Monitoring Dementia Progression

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele, Roma, Italy

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Identification of Disease-Associated Phenotypes in MCI and AD

    Time frame: through study completion, an average of 1 year

  2. Identification of Disease-Associated Early Interventions in MCI and AD

    Time frame: through study completion, an average of 1 year

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

    Time frame: through study completion, an average of 1 year

    EEG power spectral density

  4. Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation

    Time frame: through study completion, an average of 1 year

  5. Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation

    Time frame: through study completion, an average of 1 year

  6. Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages

    Time frame: through study completion, an average of 1 year

  7. Assessment of Activated Leukosomes in Glial Cells

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Gatta, PhD

CONTACT

[email protected]

+390652253440

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease

Acronym: ADvance

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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