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Completed

NCT Number: NCT05989087

The Resting-state EEG Gamma Oscillations in Alzheimer's Disease

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.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İzmir University of Economics

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CSF

Diagnostic Test

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

Other names: MRI, Neuropsychological tests

Primary outcomes

  1. EEG

    Time frame: Day 2

    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.

Secondary outcomes

  1. Correlation Analysis

    Time frame: 3 months

    Correlations between CSF, neuropsychological tests (NPT), EEG, and MRI measures were investigated.

  2. Discriminant Analysis

    Time frame: 3 months

    The discriminative power of gamma measures (power and coherence) was investigated with discriminant analysis (DA).

  3. MRI

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Görsev Yener, MD, PhD

Other

Registry information

Official study title

The Underestimated Utility of Resting-state Gamma Oscillations: Both Increase and Decrease of Gamma Discriminates Early-onset Alzheimer's Disease Patients From Healthy Individuals

Acronym: EEG

Important dates

Study start
2012
Primary completion
2016
Study completion
2019
First posted
Aug 14, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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