Mild Cognitive ImpairmentNCT04954183
Development of an EEG Diagnostic for Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to collect and compare electroencephalogram data from all stages of Alzheimer's disease from preclinical through severe dementia. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 24 Jul 2025
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies, Normal Control APOE e4 Carriers and Noncarriers
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Lewy Body Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain electroencephalogram (EEG) data
Number of EEG data on individuals at all stages of Alzheimer's disease from preclinical through severe dementia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Oct 2021
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Spark Neuro Inc.
- Responsible party
- Principal investigator, Erik K. St Louis, Mayo Clinic
- Investigators
- Erik K. St. Louis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954183
- Sponsor's protocol ID
- 21-000676
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an EEG Diagnostic for Alzheimer's Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04954183
- Acronym / sponsor ID
- 21-000676
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies, Normal Control APOE e4 Carriers and Noncarriers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Spark Neuro Inc.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 8 Jul 2021 (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 purpose of this research is to collect and compare electroencephalogram data from all stages of Alzheimer's disease from preclinical through severe dementia.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 25 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Erik K. St. Louis, MD principal investigator
Mayo Clinic
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 Mild Cognitive Impairment and Alzheimer Disease, run by Mayo Clinic at 1 site in United States.
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 6 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 25 Sep 2025. 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 United States. 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?
Obtain electroencephalogram (EEG) data (time frame: 1 year). 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 25 Sep 2025.