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ENROLLING BY INVITATION

NCT06826157

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Official title: Assessing the Role of Advanced Electroencephalographic Data as Marker of Pathology and Prognosis in Primary Dementias

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2021-11-05

Completion Date

2027-01-01

Last Updated

2025-02-17

Healthy Volunteers

Yes

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

Inclusion criteria for all study subjects: * right-handed participants; * monolingual native Italian speakers; * age between 50-85 years old; * normal or corrected-to-normal visual acuity; * oral and written informed consent to study participation. * if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks. Inclusion criteria for MCI patients: * diagnosis of amnestic MCI; * mini Mental State Examination (MMSE) score ≥ 24; * if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks; * available CSF AD biomarkers. Inclusion criteria for patients with mild dementia: * diagnosis of AD dementia, FTD or LBD. * MMSE score ≥ 15; * if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks. Exclusion criteria for patients: * secondary forms of cognitive impairment on the basis of historical data, neurologic examination, and cerebral neuroimaging findings; * very rapid cognitive decline that occurs over weeks or months, typically indicative of prion disease, neoplasm or metabolic disorders; * history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations; * alcohol and/or psychotropic drugs abuse; * enrolment in clinical trials testing disease-modifying drugs for AD during study; * contraindications to MRI study: 1. Cardiac pacemakers or other types of cardiac catheters; 2. metal splinters or fragments; 3. metal prostheses not compatible with the magnetic field generated during MRI; 4. claustrophobia. * Women who are pregnant or intending to become pregnant during the study; breastfeeding women. Exclusion criteria for healthy controls * History of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations; * alcohol and/or psychotropic drugs abuse; * contraindications to MRI study (see above); * women who are pregnant or intending to become pregnant during the study; breastfeeding women.

Locations (1)

IRCCSS San Raffaele

Milan, Italy, Italy