Biomarkers for Monitoring Dementia Progression (ADvance)

IRCCS San Raffaele Roma

Status: Enrolling

Conditions: Alzheimer Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06855368

RP 22/25

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 3 patient groups

AD

MCI

HC