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Search / Trial NCT06826157

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

Launched by IRCCS SAN RAFFAELE · Feb 10, 2025

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

High Definition Electroencephalogram Brain Magnetic Resonance Imaging Biomarker Profile Positron Emission Tomography Apolipoprotein E Mild Cognitive Impairment Frontotemporal Dementia Lewy Body Dementia Dementia

ClinConnect Summary

The main aim of the project is to examine resting-state high definition EEG cortical sources of participants diagnosed with amnestic MCI with the goal of:

- exploring EEG-markers of Alzheimer's disease pathology and their relationships with both conventional and non-conventional brain MRI data. Researchers will explore these relationships after grouping participants according to their cerebrospinal fluid (CSF) biomarkers profile.

Researchers will explain further relationships through brain Positron Tomography Emission with fluorodeoxyglucose (PET-FDG) data performed during clinical diagno...

Gender

ALL

Eligibility criteria

  • 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.

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Milano, , Italy

Patients applied

0 patients applied

Trial Officials

Massimo MF Filippi, MD

Principal Investigator

IRCCS Ospedale San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported