NCT06826157Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Interventional
Enrollment: 175 (estimated)
First submitted: 4 Dec 2024
Start date: 5 Nov 2021
Primary completion date: 15 Apr 2026
Lead sponsor: IRCCS San Raffaele
Diseases: Frontotemporal dementia, Lewy body dementia, Alzheimer disease
NCT number: NCT06826157

What you commit to

Study type: Interventional
Planned participants: 175
From 5 Nov 2021 to the primary completion date, 15 Apr 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

alcohol and/or psychotropic drugs abuse;
alcohol and/or psychotropic drugs abuse;

Other illness

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;
enrolment in clinical trials testing disease-modifying drugs for AD during study;
contraindications to MRI study:
- Cardiac pacemakers or other types of cardiac catheters;
- metal splinters or fragments;
- metal prostheses not compatible with the magnetic field generated during MRI;
- claustrophobia.
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;

Other

Women who are pregnant or intending to become pregnant during the study; breastfeeding women.
contraindications to MRI study (see above);
women who are pregnant or intending to become pregnant during the study; breastfeeding women.

Who the study is looking for

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.

Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
IRCCSS San Raffaele Coordinator of this site? Confirm its status	Milan	Italy	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.