Early Onset Alzheimer Disease(BNA™)NCT02875496
Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain
An observational study of Early Onset Alzheimer Disease and Mild Cognitive Impairment, run by ElMindA Ltd at 1 site in United States.
Trial summary
Establishment of a BNA reference database for the Adult and Elderly Population. Hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Onset Alzheimer Disease, Mild Cognitive Impairment, Depression
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 2000 subjects, from both genders, aged 50- years and above will be recruited and stratified to age groups. Once enrollment reaches the below numbers for each age group, subjects will be statistically stratified and analyzed in 4 different Arms, one Normative and three Pathologies, according to a prospective statistical plan and based on the prevalence of common pathological conditions in each age group; this will be determined by analysis of the literature, analysis of study demographics and concomitant diseases, and on the PI and/or sponsor's discretion. Suggested enrollment numbers for the different age groups and different Arms are:
Who may be able to join
- Currently resides in The Villages community
- Age 50-years and above.
- Able to speak, read and understand English
- Willingness to participate and able to give informed consent.
- If corrected vision: only Glasses should be used during the study testing
- BDI score <14
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- Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR,
- MMSE score ≥25
- BDI score <14
- Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR, as determined by clinical evaluation by a research clinician and the Mini International Neuropsychiatric Interview (MINI).
- MMSE score <24
- MoCA<20
- Presence of an early and significant episodic memory impairment
- BDI score >14
- Subjects meeting full diagnostic criteria for MDD without psychotic features per the DSM IV-TR
- HAM-D 17-item: Total score of 16 or higher at visit 1.
- BDI score <14
- Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR
- MMSE scores according to Number of years of Education:
- MMSE score Years of Education 17-18 ≤6 20-21 7-8 23-24 ≥10
- -20<MoCA score >26
Who cannot join
- Currently with lice or open wounds on scalp.
- Any CNS neurologic disorder
- Significant sensory deficits.
- Use of a hearing aid that occupies the ear canal
- Any neuropsychological disorders
- History of special education
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- Substance abuse in the last 3 months
- History of any clinically significant brain trauma as determined by the investigator.
- Clinically diagnosed with a concussion in the past year.
- For Arm 1 Healthy
- Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
- Any psychiatric disorder,
- History of any medication affecting CNS within the last 3 months
- For Arm 2 Early Alzheimer's Disease
- Any chronic disease or condition other than current pathology
- Any other psychiatric disorder
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
- For Arm 3 Depression
- Any chronic disease or condition other than current pathology
- Any psychiatric disorder other than Depression
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
- For Arm 4 Mild Cognitive Impairment
- Any chronic disease or condition other than current pathology
- Any other psychiatric disorder
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Villages Health
The Villages, Florida, 32162
Carla VanderWeerd, PhD, 352-674-8859, research@thevillageshealth.com
Jeffrey Lowenkron, MD
About this study
Official title: Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain: Brain Network Activation Analysis (BNA™) for the Adult and Elderly Population Using Evoked Response Potentials
Establishment of a BNA reference database for the Adult and Elderly Population. Hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
Read the detailed description
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording, spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.
The need of objective measures that will help the clinician in its decision-making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy aging | Subjects meeting criteria for healthy aging No intervention administered | |
| Early Alzheimer Disease | Subjects meeting criteria for Early Alzheimer Disease No intervention administered | |
| Depression | Subjects meeting criteria for Depression No intervention administered | |
| MCI-Mild Cognitive Impairment | Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered | |
| General Arm | Subjects not meeting criteria for any of the other arms (Healthy, Early Alzheimer's, Depression, or MCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a BNA database for healthy aging population.
Functional networks of brain activity in healthy aging individuals measured using analysis of EEG Event Related Potential (ERP) data Clinical assessments battery will be utilized in order to establish different sets of BNA database for age related pathology and healthy aging.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Onset Alzheimer DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Lowenkron, MD, Principal investigator, Chief Medical Officer, The Villages HealthCarla VandeWeerd, PhD, Principal investigator, Director of Research, The Villages Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875496
- Sponsor's protocol ID
- ELM-26
- Acronym
- (BNA™)
- Status last verified
- Nov 2019
- First submitted
- 4 Aug 2016
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain: Brain Network Activation Analysis (BNA™) for the Adult and Elderly Population Using Evoked Response Potentials
- ClinicalTrials.gov ID
- NCT02875496
- Acronym / sponsor ID
- (BNA™) / ELM-26
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- 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.
Establishment of a BNA reference database for the Adult and Elderly Population. Hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
Detailed description
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording, spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.
The need of objective measures that will help the clinician in its decision-making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy aging | – | –Subjects meeting criteria for healthy aging No intervention administered |
| Early Alzheimer Disease | – | –Subjects meeting criteria for Early Alzheimer Disease No intervention administered |
| Depression | – | –Subjects meeting criteria for Depression No intervention administered |
| MCI-Mild Cognitive Impairment | – | –Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered |
| General Arm | – | –Subjects not meeting criteria for any of the other arms (Healthy, Early Alzheimer's, Depression, or MCI) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 2000 subjects, from both genders, aged 50- years and above will be recruited and stratified to age groups. Once enrollment reaches the below numbers for each age group, subjects will be statistically stratified and analyzed in 4 different Arms, one Normative and three Pathologies, according to a prospective statistical plan and based on the prevalence of common pathological conditions in each age group; this will be determined by analysis of the literature, analysis of study demographics and concomitant diseases, and on the PI and/or sponsor's discretion. Suggested enrollment numbers for the different age groups and different Arms are:
Key inclusion criteria (21 listed)
- Currently resides in The Villages community
- Age 50-years and above.
- Able to speak, read and understand English
- Willingness to participate and able to give informed consent.
- If corrected vision: only Glasses should be used during the study testing
Key exclusion criteria (25 listed)
- Currently with lice or open wounds on scalp.
- Any CNS neurologic disorder
- Significant sensory deficits.
- Use of a hearing aid that occupies the ear canal
- Any neuropsychological disorders
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
Developing a BNA database for healthy aging population.
Time frame: 2 years
Functional networks of brain activity in healthy aging individuals measured using analysis of EEG Event Related Potential (ERP) data Clinical assessments battery will be utilized in order to establish different sets of BNA database for age related pathology and healthy aging.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Jeffrey Lowenkron, MD principal investigator
Chief Medical Officer, The Villages Health
Carla VandeWeerd, PhD principal investigator
Director of Research, The Villages Health
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 Early Onset Alzheimer Disease and Mild Cognitive Impairment, run by ElMindA Ltd 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 21 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla VandeWeerd, PhD (352-674-8859, research@thevillageshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing a BNA database for healthy aging population. (time frame: 2 years). 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 27 Nov 2019.