Alzheimer Disease, Early OnsetEEGNCT05989087
The Resting-state EEG Gamma Oscillations in Alzheimer's Disease
An observational study of Alzheimer Disease, Early Onset, run by Görsev Yener, MD, PhD at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- CSF
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2012to 5 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The present study included a retrospective investigation of EEG and MRI data. The total sample for the study consisted of 24 early-onset Alzheimer's disease patients and 24 healthy controls.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- CSF
- Keywords
- Alzheimer's disease, Gamma activity, Resting-state EEG, Discriminative power, MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSFDiagnostic test
Also called MRI, Neuropsychological tests
Early-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests.
| Study group | Role | What they receive |
|---|---|---|
| Early-onset Alzheimer's disease | Patients were recruited from the outpatient memory clinics of the Department of Neurology, Dokuz Eylül University Hospital. The patient group was diagnosed by an expert neurologist, according to the National Institute on Aging-Alzheimer's Association diagnostic criteria for Alzheimer's disease Receives: Diagnostic Test: CSF | |
| Healthy controls | Age-and gender-matched healthy volunteers were recruited via advertisements and word-of-mouth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2
Secondary outcomes (3)
Correlation Analysis
Correlations between CSF, neuropsychological tests (NPT), EEG, and MRI measures were investigated.
Measured: 3 months
Discriminant Analysis
The discriminative power of gamma measures (power and coherence) was investigated with discriminant analysis (DA).
Measured: 3 months
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start7 Nov 2012
- Primary completion2 Jan 2016
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Görsev Yener, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Görsev Yener, MD, PhD, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989087
- Sponsor's protocol ID
- DokuzEU EEG
- Acronym
- EEG
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the contact person, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05989087
- Acronym / sponsor ID
- EEG / DokuzEU EEG
- Conditions
- Alzheimer Disease, Early Onset
- Keywords
- Alzheimer's disease, Gamma activity, Resting-state EEG, Discriminative power, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Görsev Yener, MD, PhDUniversity, hospital or other
- Study start
- 7 Nov 2012 (actual)
- Primary completion
- 2 Jan 2016 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-onset Alzheimer's disease | – | Diagnostic Test: CSFPatients were recruited from the outpatient memory clinics of the Department of Neurology, Dokuz Eylül University Hospital. The patient group was diagnosed by an expert neurologist, according to the National Institute on Aging-Alzheimer's Association diagnostic criteria for Alzheimer's disease |
| Healthy controls | – | –Age-and gender-matched healthy volunteers were recruited via advertisements and word-of-mouth. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The present study included a retrospective investigation of EEG and MRI data. The total sample for the study consisted of 24 early-onset Alzheimer's disease patients and 24 healthy controls.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSFAlso: MRI, Neuropsychological testsEarly-onset Alzheimer's disease patients underwent routine laboratory tests to obtain CSF samples. Also, all participants underwent structural MRI examinations and neuropsychological tests. | Diagnostic test | Early-onset Alzheimer's disease |
Primary outcome
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.
3 secondary outcomes
Correlation Analysis
Time frame: 3 months
Discriminant Analysis
Time frame: 3 months
MRI
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the contact person, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset, run by Görsev Yener, MD, PhD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.