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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05989087
Other study ID # DokuzEU EEG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2012
Est. completion date April 5, 2019

Study information

Verified date August 2023
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The literature suggests a strong association between amyloid accumulation and gamma alterations, emerging gamma activity as a biomarker candidate for Alzheimer's pathology. The present study aims to investigate resting-state gamma activity changes in Cerebrospinal fluid (CSF)-proven early-onset Alzheimer's disease (EOAD) patients with a holistic approach that employs structural and functional brain neuroimaging techniques, and neuropsychological aspects.


Description:

This cross-sectional study included 24 drug-naive CSF-proven EOAD patients and age-, sex, and education-matched healthy controls. All participants underwent a detailed neuropsychological evaluation, resting-state electroencephalography (EEG) recording, and Magnetic Resonance Imaging (MRI). Gamma power and coherence were measured in total gamma (30-48 Hz), gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz) frequency bands. Gray matter volumes were extracted for 54 regions of interest (ROIs) and compared between groups. Discriminant analysis was performed to determine the classification accuracy of gamma activity for EOAD. Finally, correlations between CSF, neuropsychological tests, EEG, and MRI measures were explored.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 5, 2019
Est. primary completion date January 2, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 65 Years
Eligibility Inclusion Criteria: - For all participants: Age < 65 - For EOAD patients: Meeting National Institute on Aging-Alzheimer's Association diagnostic criteria. - For healthy controls: Mini-Mental State Examination (MMSE) >25 Instrumental Activities of Daily Living Scale (IADL) = 8 Exclusion Criteria: - For EOAD patients: MMSE > 24 Geriatric depression scale (GDS) > 14 Having treatment with antipsychotics and comorbidities that may affect cognitive abilities. - For healthy controls: Having neurological and/or cognitive abnormalities Having a history of neurological, psychiatric, or systemic disorders, and alcohol/drug abuse. GDS > 14 - For all participants: Having neurological (other than AD) or any other serious disease (cancer, systemic disease)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CSF
Early-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests.

Locations

Country Name City State
Turkey Izmir University of Economics Izmir

Sponsors (1)

Lead Sponsor Collaborator
Görsev Yener, MD, PhD

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG The resting state EEG recordings were acquired using Easy-Cap comprising 30 Ag/AgCl electrodes placed according to the international 10-20 system. Coherence and maximum peak power of the total gamma (30-48 Hz) and sub-gamma bands [gamma-1 (30-35 Hz), gamma-2 (35-40 Hz), and gamma-3 (40-48 Hz)] were measured for each participant. Day 2
Secondary Correlation Analysis Correlations between CSF, neuropsychological tests (NPT), EEG, and MRI measures were investigated. 3 months
Secondary Discriminant Analysis The discriminative power of gamma measures (power and coherence) was investigated with discriminant analysis (DA). 3 months
Secondary MRI Participants underwent structural magnetic resonance imaging on a Philips Achieva 1.5 Tesla scanner. The gray matter volumes were obtained from the 3D-T1 weighted Turbo field echo (TFE) sequence (TR: 9ms, Time to Echo (TE): 4ms, Field-of-view (FOV): 240mm, matrix: 256, slice thickness: 1mm, numbers of signal averages (NSA): 1). The images were segmented into gray matter, white matter, and CSF with the default parameters of the CAT12 segmentation function. Only the gray matter calculations were compared between groups. Day 1
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