Alzheimer DiseaseEASESNCT03644043
Evidence Amyloid Scan EEG Study
An observational study of Alzheimer Disease and Dementia Frontal, run by Metabolic Therapy Inc. at 1 site in United States.
Trial summary
The Evidence Amyloid Study EEG (EASE) establishes an open-label, longitudinal cohort study to measure of neurological functioning during the onset and progression of cognitive decline in preclinical Alzheimer's patients using quantitative electroencephalography (qEEG) measures (P300, P50, and reaction time). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia Frontal, Mild Cognitive Impairment
- What is being tested?
- EEG scan
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 30 Nov 2020
- How long will I take part?
- 24 Months
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must be referred by qualified dementia specialists for EEG brain scan.
Who may be able to join
- 65 and older;
- Medicare beneficiary;
- Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- Alzheimer's disease is a diagnostic considerationExclusion Criteria:
- Head MRI and/or CT within 24 months prior to enrollment;
Who cannot join
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Translational Cognitive Research
Houston, Texas, 77036
Dewey Brown II, PhD
About this study
Official title: Quantitative EEG for Assessment of Mild Cognitive Impairment Associated With Preclinical Alzheimer's Disease - Evidence for Amyloid Indication Study
The Evidence Amyloid Study EEG (EASE) establishes an open-label, longitudinal cohort study to measure of neurological functioning during the onset and progression of cognitive decline in preclinical Alzheimer's patients using quantitative electroencephalography (qEEG) measures (P300, P50, and reaction time). Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi headset with the WAVi EEG P300/P50 system, along with the structured clinical interviews and assessments for baseline screening or mild cognitive impairment which are standard of care.
Read the detailed description
Obtain and analyze in-vivo EEG data in participants ages 50-65 showing early onset symptomology of MCI for the purpose of guiding patient management and developing intervention methods for improving overall health outcomes for this segment of the population. Both healthy and symptomatic groups will be populated by participants with previous PET amyloid-beta (Aβ) imaging scans. Incorporate WAVi brain scan technology which has proven effective in assessing cases of mTBI.
Quantitative electroencephalograph (qEEG) is a non-invasive assessment which records multi-channel EEG event-related potentials (ERPs) and a comprehensive multi-dimensional analysis of such recordings by advanced algorithms aimed at understanding and visualizing the network complexity of brain function. Our goal is to compare assessments from both symptomatic and asymptomatic individuals to further develop differential diagnoses in the early-most stages of preclinical AD. Expounding upon an investigative technique that has shown promise in identifying region-specific abnormalities in concussed patients not only allows us to take advantage of an existing framework which provides a clear and elegant topographical output but also establishes a repeatable metric for quantifying MCI related dysfunction. Abiding by the measures within the existing framework contributes to a more standardized neurodiagnostic approach for dementia-related pathologies and supports continuity of care.
Ultimately this neurophysiological assessment will shed new light on the progression of cognitive impairment and the response of developing therapeutic interventions for a variety of neurologic, psychiatric and behavioral conditions. The WAVi system uses algorithms and sets of signal processing and pattern recognition techniques to seek and map activated neural pathways in task-related data points with respect to time, location, amplitude, and frequency. By projecting the individual data points into clusters, they reveal three-dimensional images of brain network activation patterns which represent high resolution functional neural pathways. These brain network patterns and scores can aid clinicians with profiling of brain functionality in comparison to the reference brain network model to assess similarity to normal brain functioning. Measuring alterations in functionality and/or dysfunctionality can potentially assist treatment courses following changes in disease progression. When combined with data supplied from information from self-reported and observed cognitive and behavior patterns clarity arises with respect to brain processes and determination of the medical condition.
For this investigation we will evaluate the ability of qEEG P300 and P50 waveform amplitudes and auditory response times to differentiate healthy aging individuals from those developing MCI characteristics. WAVi recording in the awake-responding state is an ideal low-cost and non-invasive methodology with a high temporal resolution (milliseconds) that provides an optimal investigational tool for the emerging features of brain pathophysiology. These procedures are well-tolerated by patients, unaffected by task difficulty and are widely available to all subpopulations, even those traditionally underrepresented in clinical study. Additionally, they can be repeated over time without habituation effects.
Aim 1 determines individual baseline qEEG P300/P50 amplitudes and auditory response times in a population of healthy participants ages 50-65 without a history of dementia that have previously received PET scan imaging. Assess the population mean, median and variability. If possible, a subset will be retested at a standard interval to determine test-retest reliability for this instrument.
Aim 2 evaluates the ability of qEEG P300 amplitudes and auditory response times to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age.
Aim 3 evaluates the ability of qEEG P50 amplitudes to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age.
Aim 4 confirms the efficacy of qEEG/amyloid plaque loading correlation with previous PET scan imaging data.
- Being tested
- EEG scan
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG scanDevice
WAVi EEG and evoked potential platform. Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi Headset with the WAVi Co EEG P300 system, along with the structured clinical interviews and assessments for the various ailments or baseline screenings
| Study group | Role | What they receive |
|---|---|---|
| Early stage of MCI symptoms | Subjects with cognitive decline representing MCI symptomology and with previous PET amyloid-beta (Aβ) imaging results. Receives: Device: EEG scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient meeting Appropriate Use Criteria (AUC) with EEG brain scan - P300 and P50 will be measured for correlation between P300 and P50 with amyloid deposition.
Test whether qEEG P300 and P50 waveform amplitudes and auditory response times will lead to correlation with amyloid deposition
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start20 Jul 2018
- Primary completion15 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for 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)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Metabolic Therapy Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Asian American Adult Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644043
- Sponsor's protocol ID
- 1R02TCR0072518
- Acronym
- EASES
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Smailovic U, Koenig T, Kareholt I, Andersson T, Kramberger MG, Winblad B, Jelic V. Quantitative EEG power and synchronization correlate with Alzheimer's disease CSF biomarkers. Neurobiol Aging. 2018 Mar;63:88-95. doi: 10.1016/j.neurobiolaging.2017.11.005. Epub 2017 Nov 16.
PubMed 29245058Kramberger MG, Kareholt I, Andersson T, Winblad B, Eriksdotter M, Jelic V. Association between EEG abnormalities and CSF biomarkers in a memory clinic cohort. Dement Geriatr Cogn Disord. 2013;36(5-6):319-28. doi: 10.1159/000351677. Epub 2013 Sep 10.
PubMed 24022277Stomrud E, Hansson O, Minthon L, Blennow K, Rosen I, Londos E. Slowing of EEG correlates with CSF biomarkers and reduced cognitive speed in elderly with normal cognition over 4 years. Neurobiol Aging. 2010 Feb;31(2):215-23. doi: 10.1016/j.neurobiolaging.2008.03.025.
PubMed 18462837Michel CM. Electrical Neuroimaging. Cambridge University Press, Cambridge 2009.
Freire FR, Coelho F, Lacerda JR, da Silva MF, Goncalves VT, Machado S, Velasques B, Ribeiro P, Basile LFH, Oliveira AMP, Paiva WS, Kanda PAM, Anghinah R. Cognitive rehabilitation following traumatic brain injury. Dement Neuropsychol. 2011 Jan-Mar;5(1):17-25. doi: 10.1590/S1980-57642011DN05010004.
PubMed 292137151. Cassani R, Falk TH, Fraga FJ, Cecchi M, Moore DK, Anghinah R. Towards automated electroencephalography-based Alzheimer's disease diagnosis using portable low-density devices. Biomedical Signal Processing and Control. 2017,33:261-71.
Pratap-Chand R, Sinniah M, Salem FA. Cognitive evoked potential (P300): a metric for cerebral concussion. Acta Neurol Scand. 1988 Sep;78(3):185-9. doi: 10.1111/j.1600-0404.1988.tb03643.x.
PubMed 3227804Olichney JM, Yang JC, Taylor J, Kutas M. Cognitive event-related potentials: biomarkers of synaptic dysfunction across the stages of Alzheimer's disease. J Alzheimers Dis. 2011;26 Suppl 3(0 3):215-28. doi: 10.3233/JAD-2011-0047.
PubMed 21971462Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
PubMed 27239520van Dinteren R, Arns M, Jongsma ML, Kessels RP. P300 development across the lifespan: a systematic review and meta-analysis. PLoS One. 2014 Feb 13;9(2):e87347. doi: 10.1371/journal.pone.0087347. eCollection 2014.
PubMed 24551055Polich J, Corey-Bloom J. Alzheimer's disease and P300: review and evaluation of task and modality. Curr Alzheimer Res. 2005 Dec;2(5):515-25. doi: 10.2174/156720505774932214.
PubMed 16375655Polich J, Ladish C, Bloom FE. P300 assessment of early Alzheimer's disease. Electroencephalogr Clin Neurophysiol. 1990 May-Jun;77(3):179-89. doi: 10.1016/0168-5597(90)90036-d.
PubMed 1691970Frodl T, Hampel H, Juckel G, Burger K, Padberg F, Engel RR, Moller HJ, Hegerl U. Value of event-related P300 subcomponents in the clinical diagnosis of mild cognitive impairment and Alzheimer's Disease. Psychophysiology. 2002 Mar;39(2):175-81. doi: 10.1017/S0048577202010260.
PubMed 12212666Bennys K, Portet F, Touchon J, Rondouin G. Diagnostic value of event-related evoked potentials N200 and P300 subcomponents in early diagnosis of Alzheimer's disease and mild cognitive impairment. J Clin Neurophysiol. 2007 Oct;24(5):405-12. doi: 10.1097/WNP.0b013e31815068d5.
PubMed 17912065Papaliagkas VT, Anogianakis G, Tsolaki MN, Koliakos G, Kimiskidis VK. Combination of P300 and CSF beta-amyloid(1-42) assays may provide a potential tool in the early diagnosis of Alzheimer's disease. Curr Alzheimer Res. 2010 Jun;7(4):295-9. doi: 10.2174/156720510791162421.
PubMed 19939224
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative EEG for Assessment of Mild Cognitive Impairment Associated With Preclinical Alzheimer's Disease - Evidence for Amyloid Indication Study
- ClinicalTrials.gov ID
- NCT03644043
- Acronym / sponsor ID
- EASES / 1R02TCR0072518
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Metabolic Therapy Inc.University, hospital or other
- Collaborators
- Institute of Asian American Adult Development
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 23 Aug 2018 (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 Evidence Amyloid Study EEG (EASE) establishes an open-label, longitudinal cohort study to measure of neurological functioning during the onset and progression of cognitive decline in preclinical Alzheimer's patients using quantitative electroencephalography (qEEG) measures (P300, P50, and reaction time). Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi headset with the WAVi EEG P300/P50 system, along with the structured clinical interviews and assessments for baseline screening or mild cognitive impairment which are standard of care.
Detailed description
Obtain and analyze in-vivo EEG data in participants ages 50-65 showing early onset symptomology of MCI for the purpose of guiding patient management and developing intervention methods for improving overall health outcomes for this segment of the population. Both healthy and symptomatic groups will be populated by participants with previous PET amyloid-beta (Aβ) imaging scans. Incorporate WAVi brain scan technology which has proven effective in assessing cases of mTBI.
Quantitative electroencephalograph (qEEG) is a non-invasive assessment which records multi-channel EEG event-related potentials (ERPs) and a comprehensive multi-dimensional analysis of such recordings by advanced algorithms aimed at understanding and visualizing the network complexity of brain function. Our goal is to compare assessments from both symptomatic and asymptomatic individuals to further develop differential diagnoses in the early-most stages of preclinical AD. Expounding upon an investigative technique that has shown promise in identifying region-specific abnormalities in concussed patients not only allows us to take advantage of an existing framework which provides a clear and elegant topographical output but also establishes a repeatable metric for quantifying MCI related dysfunction. Abiding by the measures within the existing framework contributes to a more standardized neurodiagnostic approach for dementia-related pathologies and supports continuity of care.
Ultimately this neurophysiological assessment will shed new light on the progression of cognitive impairment and the response of developing therapeutic interventions for a variety of neurologic, psychiatric and behavioral conditions. The WAVi system uses algorithms and sets of signal processing and pattern recognition techniques to seek and map activated neural pathways in task-related data points with respect to time, location, amplitude, and frequency. By projecting the individual data points into clusters, they reveal three-dimensional images of brain network activation patterns which represent high resolution functional neural pathways. These brain network patterns and scores can aid clinicians with profiling of brain functionality in comparison to the reference brain network model to assess similarity to normal brain functioning. Measuring alterations in functionality and/or dysfunctionality can potentially assist treatment courses following changes in disease progression. When combined with data supplied from information from self-reported and observed cognitive and behavior patterns clarity arises with respect to brain processes and determination of the medical condition.
For this investigation we will evaluate the ability of qEEG P300 and P50 waveform amplitudes and auditory response times to differentiate healthy aging individuals from those developing MCI characteristics. WAVi recording in the awake-responding state is an ideal low-cost and non-invasive methodology with a high temporal resolution (milliseconds) that provides an optimal investigational tool for the emerging features of brain pathophysiology. These procedures are well-tolerated by patients, unaffected by task difficulty and are widely available to all subpopulations, even those traditionally underrepresented in clinical study. Additionally, they can be repeated over time without habituation effects.
Aim 1 determines individual baseline qEEG P300/P50 amplitudes and auditory response times in a population of healthy participants ages 50-65 without a history of dementia that have previously received PET scan imaging. Assess the population mean, median and variability. If possible, a subset will be retested at a standard interval to determine test-retest reliability for this instrument.
Aim 2 evaluates the ability of qEEG P300 amplitudes and auditory response times to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age.
Aim 3 evaluates the ability of qEEG P50 amplitudes to discriminate between aged participants with MCI/preclinical AD symptoms and healthy participants of similar age.
Aim 4 confirms the efficacy of qEEG/amyloid plaque loading correlation with previous PET scan imaging data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage of MCI symptoms | – | Device: EEG scanSubjects with cognitive decline representing MCI symptomology and with previous PET amyloid-beta (Aβ) imaging results. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must be referred by qualified dementia specialists for EEG brain scan.
Key inclusion criteria (6 listed)
- 65 and older;
- Medicare beneficiary;
- Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- Alzheimer's disease is a diagnostic considerationExclusion Criteria:
Key exclusion criteria (6 listed)
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Life expectancy less than 24 months based on medical co-morbidities;
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 |
|---|---|---|
| EEG scanWAVi EEG and evoked potential platform. Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi Headset with the WAVi Co EEG P300 system, along with the structured clinical interviews and assessments for the various ailments or baseline screenings | Device | Early stage of MCI symptoms |
Primary outcome
Patient meeting Appropriate Use Criteria (AUC) with EEG brain scan - P300 and P50 will be measured for correlation between P300 and P50 with amyloid deposition.
Time frame: 10 days
Test whether qEEG P300 and P50 waveform amplitudes and auditory response times will lead to correlation with amyloid deposition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 29245058Smailovic U, Koenig T, Kareholt I, Andersson T, Kramberger MG, Winblad B, Jelic V. Quantitative EEG power and synchronization correlate with Alzheimer's disease CSF biomarkers. Neurobiol Aging. 2018 Mar;63:88-95. doi: 10.1016/j.neurobiolaging.2017.11.005. Epub 2017 Nov 16.
- Background: PubMed 24022277Kramberger MG, Kareholt I, Andersson T, Winblad B, Eriksdotter M, Jelic V. Association between EEG abnormalities and CSF biomarkers in a memory clinic cohort. Dement Geriatr Cogn Disord. 2013;36(5-6):319-28. doi: 10.1159/000351677. Epub 2013 Sep 10.
- Background: PubMed 18462837Stomrud E, Hansson O, Minthon L, Blennow K, Rosen I, Londos E. Slowing of EEG correlates with CSF biomarkers and reduced cognitive speed in elderly with normal cognition over 4 years. Neurobiol Aging. 2010 Feb;31(2):215-23. doi: 10.1016/j.neurobiolaging.2008.03.025.
- BackgroundMichel CM. Electrical Neuroimaging. Cambridge University Press, Cambridge 2009.
- Background: PubMed 29213715Freire FR, Coelho F, Lacerda JR, da Silva MF, Goncalves VT, Machado S, Velasques B, Ribeiro P, Basile LFH, Oliveira AMP, Paiva WS, Kanda PAM, Anghinah R. Cognitive rehabilitation following traumatic brain injury. Dement Neuropsychol. 2011 Jan-Mar;5(1):17-25. doi: 10.1590/S1980-57642011DN05010004.
- Background1. Cassani R, Falk TH, Fraga FJ, Cecchi M, Moore DK, Anghinah R. Towards automated electroencephalography-based Alzheimer's disease diagnosis using portable low-density devices. Biomedical Signal Processing and Control. 2017,33:261-71.
- Background: PubMed 3227804Pratap-Chand R, Sinniah M, Salem FA. Cognitive evoked potential (P300): a metric for cerebral concussion. Acta Neurol Scand. 1988 Sep;78(3):185-9. doi: 10.1111/j.1600-0404.1988.tb03643.x.
- Background: PubMed 21971462Olichney JM, Yang JC, Taylor J, Kutas M. Cognitive event-related potentials: biomarkers of synaptic dysfunction across the stages of Alzheimer's disease. J Alzheimers Dis. 2011;26 Suppl 3(0 3):215-28. doi: 10.3233/JAD-2011-0047.
- Background: PubMed 27239520Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
- Background: PubMed 24551055van Dinteren R, Arns M, Jongsma ML, Kessels RP. P300 development across the lifespan: a systematic review and meta-analysis. PLoS One. 2014 Feb 13;9(2):e87347. doi: 10.1371/journal.pone.0087347. eCollection 2014.
- Background: PubMed 16375655Polich J, Corey-Bloom J. Alzheimer's disease and P300: review and evaluation of task and modality. Curr Alzheimer Res. 2005 Dec;2(5):515-25. doi: 10.2174/156720505774932214.
- Background: PubMed 1691970Polich J, Ladish C, Bloom FE. P300 assessment of early Alzheimer's disease. Electroencephalogr Clin Neurophysiol. 1990 May-Jun;77(3):179-89. doi: 10.1016/0168-5597(90)90036-d.
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Aging
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.
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 and Dementia Frontal, run by Metabolic Therapy Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 23 Aug 2018. 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 Dewey Brown II, PhD (2145174004, kruss3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient meeting Appropriate Use Criteria (AUC) with EEG brain scan - P300 and P50 will be measured for correlation between P300 and P50 with amyloid deposition. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644043, which also lists 22 linked publications.
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 23 Aug 2018.