The Role of Advanced Electroencephalographic Data as Marker of Pathology and Prognosis in Primary Dementias

NCT06826157 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-02-17

No results posted yet for this study

Summary

The study aims to use advanced brainwave recordings of electroencephalogram (EEG) to understand early signs of Alzheimer's disease (AD) in people with mild memory problems, known as amnestic Mild Cognitive Impairment (MCI). The goals of the study are to:

1. Find early markers of Alzheimer by analyzing EEG recordings, the researchers hope to identify patterns that indicate the presence of Alzheimer's disease. They will compare these patterns with other brain scans, like Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans, and look at different biological markers in the participants' spinal fluid and genetic data.
2. Predict the risk of Alzheimer's disease. The study will try to find EEG patterns that can predict whether someone with MCI will develop full-blown Alzheimer's disease. The aim is to create a system that combines EEG data with other brain scans and genetic information to better understand the risk of disease progression.
3. Track changes over time: The research will also monitor changes in brain activity and structure over time to understand how Alzheimer's disease progresses.

In addition to studying people with MCI, the researchers will also look at EEG patterns in people with mild Alzheimer's disease (MILD AD), frontotemporal dementia (FTD), and Lewy-body dementia (LBD) to see how these patterns differ across various brain conditions. This could help improve the accuracy of diagnosing these diseases and understanding their link to genetic factors.

Conditions

  • Alzheimer Disease
  • Lewy Body Dementia (LBD)
  • Mild Alzheimer Disease
  • Frontotemporal Dementia (FTD)
  • Mild Cognitive Impairment (MCI)
  • Healthy Subjects

Interventions

DIAGNOSTIC_TEST

Electroencephalogram

EEGs will be acquired to explore progressive alteration of EEG patterns throughout the neuropathology progression.

DIAGNOSTIC_TEST

3 Tesla MRI

MRI evaluations will be performed to investigate structural alterations and resting state functional MRI (RS-fMRI) connectivity in participants. Longitudinal measures of cortical/subcortical atrophy and RS-fMRI connectivity will be assessed and their relationship with EEG parameters will be explored.

GENETIC

Apolipoprotein E genetic test

At baseline, a sample of blood will be collected to perform genetic analysis (APOE alleles) for all participants

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Massimo MF Filippi, MD · IRCCS Ospedale San Raffaele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2026-04-15
Completion
2027-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06826157 on ClinicalTrials.gov