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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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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 diagnostic work-up and with Apolipoprotein E (APOE) gene profile.

* prospectively identifying EEG-markers predictive of clinical conversion to full-blown AD dementia and defining an algorithm for risk stratification by combining them with brain MRI, brain FDG-PET and genetic data;
* assessing the longitudinal changes of electrophysiological and MRI signals throughout the AD neuropathology progression;

The secondary aim of the project is to assess the accuracy of the Alzheimer-related EEG signal patterns identified in the MCI group. This will be done by comparing the EEG data with the APOE genetic information in a group of patients diagnosed with mild dementia due to Alzheimer's disease, frontotemporal dementia and Lewy-Body dementia

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention study, monocentric and multiparametric

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Clinical, EEG, brain MRI and genetic evaluations

Participants will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32-channel EEG and 3 Tesla MRI at baseline (T0) and every year for 3 years. Furthermore, at baseline, a known genetic risk factors for AD will be explored (e., APOE gene profile).

Group Type EXPERIMENTAL

Electroencephalogram

Intervention Type DIAGNOSTIC_TEST

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

3 Tesla MRI

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type GENETIC

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

Interventions

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Electroencephalogram

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Apolipoprotein E genetic test

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

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

* 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

* 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.

* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes