Biomarkers for Monitoring Dementia Progression

NCT ID: NCT06855368

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AD

No interventions assigned to this group

MCI

No interventions assigned to this group

HC

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele Roma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS San Raffaele

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria di Sassari

Sassari, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lucia Gatta, PhD

Role: CONTACT

+390652253440

Facility Contacts

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Franca Deriu

Role: primary

079228289

Franca Deriu

Role: backup

Other Identifiers

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RP 22/25

Identifier Type: -

Identifier Source: org_study_id

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