Alzheimer Disease Clinical Trial
Official title:
A Non-Blinded, Non-Significant Risk Study With a Non-Invasive, Passive Pressure Wave Method of Diagnosing Brain Pathologies to Develop a Diagnostic Algorithm for Alzheimer Disease and Other Dementias.
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.
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