Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia

NCT02333942 | Completed

• 1 other identifier: 082189
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Frontotemporal Lobar Degeneration; Memory Disorders

Keywords

Aging; Diagnostic Equipment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  one year

Secondary Outcomes (3)

• 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)

  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)

  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)

  one year

Study Arms (4)

Alzheimer's Disease

Nautilus NeuroWaveTM System'

Device: Nautilus NeuroWaveTM System

Mild Cognitive Impairment

Nautilus NeuroWaveTM System'

Device: Nautilus NeuroWaveTM System

Frontotemporal Lobar Degeneration

Nautilus NeuroWaveTM System'

Device: Nautilus NeuroWaveTM System

Age-Matched Controls

Nautilus NeuroWaveTM System'

Device: Nautilus NeuroWaveTM System

Interventions

Nautilus NeuroWaveTM System DEVICE

A noninvasive device to detect dementia utilizing headset and sensors

Age-Matched Controls; Alzheimer's Disease; Frontotemporal Lobar Degeneration; Mild Cognitive Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Alzheimer's Disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment, and Age-Matched Controls.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jan Medical, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of Californa San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Frontotemporal Lobar Degeneration; Memory Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aimee Kao, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: January 8, 2015
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)