- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954183
Development of an EEG Diagnostic for Alzheimer's Disease
July 3, 2023 updated by: Richard J. Caselli, Mayo Clinic
Development of an EEG Diagnostic for Alzheimer's Disease: A Feasibility Study
The purpose of this research is to collect and compare electroencephalogram data from all stages of Alzheimer's disease from preclinical through severe dementia.
Study Overview
Status
Enrolling by invitation
Detailed Description
Patients with diagnoses of sporadic and late onset Alzheimer's disease dementia, MCI, and DLB evaluated by a dementia subspecialist will meet published diagnostic criteria, and EEGs will be obtained through written informed consent.
Regarding presymptomatic patients, we have previously shown that the mean age of MCI diagnosis in our cohort is 73 years and that preclinical cognitive decline begins as much as 20 years before clinical diagnosis but is also affected by APOE genotype.
Eligibility therefore will include unimpaired APOE e4/4 homozygotes age 65-75 and APOE e3/4 heterozygotes age 75-85 for the preclinical AD subset and age, sex, and education matched APOE e4 noncarriers for the unaffected controls.
Biomarker confirmation for preclinical diagnosis will be utilized to the extent possible (a subset of 130 members of our cohort have undergone amyloid-PET resulting in approximately 45 who are amyloid positive).
EEG data will be performed during wakefulness with 15 minutes of eyes open and 15 minutes of eyes closed.
A 32 electrode cap will be applied following the 10-20 anatomical system by certified EEG technologists.
Data will be recorded using a research-grade EEG system with FDA 510(k) clearance for use in medical contexts.
Subjects will be seated in a testing room with minimal distractions.
An EEG tech will fit the subject with a cap containing NN Ag/AgCl electrodes placed according to the international 10-10 system and ensure electrode impedances stay below 10 kΩ.
Subjects will be instructed to minimize movements and remain in a relaxed but wakeful state.
We will record fifteen minutes of eyes-open resting state EEG.
Afterwards, the subjects will be instructed to close their eyes and reminded to stay relaxed but awake, and we will record fifteen minutes of eyes-closed resting state EEG.
During the recording session, a researcher will monitor the subject's behavior and the EEG signal.
The researcher will briefly prompt the subject to remain awake if the subject's behavior or EEG traces show signs of drowsiness.
All data will be de-identified then transferred to SPARK Neuro's research and development team for analysis via secure encrypted methods.
The data will be stored on password-protected computer systems, and only the necessary research and research-support staff at SPARK Neuro will have access to the data.
The SPARK Neuro research and development team will analyze de-identified patient data to address the aims of this proposal.
SPARK Neuro will use various techniques including those standard in EEG analysis (e.g.
filtering, scaling, independent components analysis), particular approaches shown to be successful in the Alzheimer's disease EEG classification literature (e.g.
coherence, relative power in standard frequency bands, functional connectivity, spectral entropy), as well as approaches from the broader machine-learning and EEG literature (e.g.
spectral clustering, convolutional neural networks, cross-frequency coupling, non-linear kernels, Katz fractal dimension, beamforming).
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects with moderate to severe dementia, mild stage dementia, amnestic MCI, presymptomatic APOE e4 carriers, and age, sex, and education matched APOE e4 noncarriers will be recruited at Mayo Clinic Arizona to obtain EEG data.
Description
Inclusion Criteria:
- 5 individuals with moderate to severe dementia, 5 with mild stage dementia, 5 with amnestic MCI, 5 presymptomatic APOE e4 carriers, and 5 age, sex, and education matched APOE e4 noncarriers. Additionally we will include a group of 5 patients with mild to moderate stage dementia with Lewy bodies (DLB), the second most common degenerative dementia, to explore differences from clinically typical Alzheimer's disease patients given the known clinical differences in EEG dysrhythmic severity between them (total of 30).
- Unimpaired APOE e4/4 homozygotes age 65-75 and APOE e3/4 heterozygotes age 75-85 for the preclinical AD subset and age, sex, and education matched APOE e4 noncarriers for the unaffected controls.
- Biomarker confirmation for preclinical diagnosis will be utilized to the extent possible (a subset of 130 members of our cohort have undergone amyloid-PET resulting in approximately 45 who are amyloid positive).
Exclusion Criteria:
- Previous stroke.
- Severe head injury.
- Craniotomy.
- Any other potentially confounding neurologic illness (typically anything that causes structural brain damage).
- Psychoactive medication use will not be an absolute exclusionary criterion in patients with moderate to severe dementia but patients who are relatively drug-free will be prioritized to the extent they are available within the study period.
- Psychoactive drug use will be exclusionary in the prospectively obtained clinical patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obtain electroencephalogram (EEG) data
Time Frame: 1 year
|
Number of EEG data on individuals at all stages of Alzheimer's disease from preclinical through severe dementia.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Caselli, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Lewy Body Disease
Other Study ID Numbers
- 21-000676
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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