NCT06826157Csak meghívásos
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. febr. 17. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 175 (tervezett)
- Első benyújtás
- 2024. dec. 4.
- Kezdés
- 2021. nov. 5.
- Elsődleges befejezés
- 2026. ápr. 15.
- Fő szponzor
- IRCCS San Raffaele
- NCT-szám
- NCT06826157
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 175
- 2021. nov. 5. és az elsődleges befejezés (2026. ápr. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- alcohol and/or psychotropic drugs abuse;
- alcohol and/or psychotropic drugs abuse;
Más betegség
- 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;
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 50 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| IRCCSS San Raffaele | Milan | Olaszország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.