Ireland
--:--IST
Latest
Clinical Trials in Italy / NCT06826157
Enrolling by invitation Not applicable

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

NCT06826157 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-11-05
Last updated
2025-02-17

Condition(s) studied

Alzheimer DiseaseLewy Body Dementia (LBD)Mild Alzheimer DiseaseFrontotemporal Dementia (FTD)Mild Cognitive Impairment (MCI)Healthy Subjects

Investigational drug(s) / intervention(s)

Electroencephalogram3 Tesla MRIApolipoprotein E genetic test

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

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.

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

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCSS San Raffaele Milan Italy

More IRCCS San Raffaele trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06826157 on ClinicalTrials.gov ↗ ← All trials in Italy