An observational study in Alzheimer Disease, Mild Cognitive Impairment and Frontotemporal Lobar Degeneration, sponsored by Jan Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by Jan Medical, Inc. · Observational
This study is being performed to generate data regarding brain vibration /oscillation differences between individuals with dementia and normal controls. The purpose of this study is to compare signal patterns generated from the impact on the scalp from these brain oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.
This is a non-blinded study in subjects who present to the UCSF Memory and Aging Clinic (MAC) with neurodegenerative disease and cognitive dysfunction. The primary objective of this non-significant risk study is signature development. The goal is to develop a signal algorithm using the Nautilus NeuroWaveTM for dementia. This is accomplished by analyzing and processing Nautilus NeuroWave recordings from a patient with confirmed dementia. All subjects will be enrolled until recordings are obtained from at least 10 of each of the following subject cohorts: Moderate or Severe Frontotemporal Lobar Degeneration (FTDL), Alzheimer's Disease, Mild Cognitive Impairment (MCI) and Age Matched Normal Controls.
As this study is a feasibility study intended to determine whether the Nautilus NeuroWave is able to generate distinctive signals correlated with dementia, statistical analysis will not be required. Similarly, the study has not been powered to attain any particular level of statistical significance. Subsequent studies will measure sensitivity and specificity of any resulting dementia signal pattern generated by this study. These future studies will be subject to statistical analysis.
The Jan Medical Nautilus NeuroWaveTM (NNW) is a non-invasive device designed to evaluate brain oscillation patterns or the brain's pulse, generated by cardiac cycle induced intracranial blood flow. The objective of the evaluation is to determine whether the oscillation pattern is normal, whether it has been disrupted, and, if disrupted, what particular disruption pattern is evident. Various cerebral pathologies studied to date with the NNW demonstrate distinct disruption patterns. These pathologies include vasospasm, concussion and arterio-venous malformation (AVM). The objective of this study is to evaluate the brain oscillation patterns from subjects with MCI, Frontotemporal dementia, AD and from a small cohort of age matched normal controls and determine whether they exhibit pattern disruption and, if so, to quantify and categorize the distinct disruption patterns. How the Nautilus NeuroWave accomplishes this is explained later in the device description section of the protocol.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 41 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Jan Medical, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Subjects with Alzheimer's Disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment, and Age-Matched Controls.
Exclusion Criteria:
Nautilus NeuroWaveTM System'
Device: Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System'
Device: Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System'
Device: Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System'
Device: Nautilus NeuroWaveTM System
A noninvasive device to detect dementia utilizing headset and sensors
Sensitivity as a diagnostic aid in detecting Dementia (identified signatures as compared with the clinical assessment made by the PI)
Efficacy at identifying Dementia through identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive at assessment.
Time frame: one year
Specificity as a diagnostic aid in detecting Dementia (Rate of false positives as compared with the clinical assessment made by the PI)
Rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Time frame: one year
Sensitivity and specificity measures for MCI and Alzheimer's disease (Efficacy and rate of false positives as compared with the clinical assessment made by the PI)
Efficacy and rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Time frame: one year
Sensitivity and specificity measures between MCI and FTDL. (distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI)
To distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Time frame: one year
Sensitivity and specificity measures between FTDL and Alzheimer's disease (distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI)
To distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment.
Time frame: one year
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Jan Medical, Inc.