Alzheimer Disease, Early Onset Clinical Trial
— EEGOfficial 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
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 |
Verified date | August 2023 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir University of Economics | Izmir |
Lead Sponsor | Collaborator |
---|---|
Görsev Yener, MD, PhD |
Turkey,
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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