Clinical trial NCT02333942: Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Frontotemporal Lobar Degeneration
Memory Disorders
Keywords: Aging
Diagnostic Equipment
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2015-01-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Alzheimer's Disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment, and Age-Matched Controls.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 years of age or older
2. Have undergone some neurologic imaging
3. Age match normal subjects and subjects with symptoms consistent with MCI, FTLD or Alzheimer's disease
4. Able to understand and provide signed informed consent, or have a legally authorized representative willing to provide informed consent on subject's behalf

Exclusion Criteria:

1. Psychologically unstable and not able to cooperate
2. Not suitable for participation in this study in the opinion of the PI
3. Patients with history of other cerebral pathologies including, head trauma or prior ICH

Primary outcomes:
measure: Sensitivity as a diagnostic aid in detecting Dementia (identified signatures as compared with the clinical assessment made by the PI)
timeFrame: one year
measure: Specificity as a diagnostic aid in detecting Dementia (Rate of false positives as compared with the clinical assessment made by the PI)
timeFrame: one year
Secondary outcomes:
measure: 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)
timeFrame: one year
measure: 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)
timeFrame: one year
measure: 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)
timeFrame: one year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of Californa San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aimee Kao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: