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Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain ((BNA™))

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ClinicalTrials.gov Identifier: NCT02875496
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd

Tracking Information
First Submitted Date August 4, 2016
First Posted Date August 23, 2016
Last Update Posted Date January 12, 2018
Study Start Date August 2016
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2016)
Developing a BNA database for healthy aging population. [ Time Frame: 2 years ]
Functional networks of brain activity in healthy aging individuals measured using analysis of EEG Event Related Potential (ERP) data Clinical assessments battery will be utilized in order to establish different sets of BNA database for age related pathology and healthy aging.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02875496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain
Official Title Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain: Brain Network Activation Analysis (BNA™) for the Adult and Elderly Population Using Evoked Response Potentials
Brief Summary Establishment of a BNA reference database for the Adult and Elderly Population. Hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
Detailed Description

Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording, spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.

The need of objective measures that will help the clinician in its decision-making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Up to 2000 subjects, from both genders, aged 50- years and above will be recruited and stratified to age groups. Once enrollment reaches the below numbers for each age group, subjects will be statistically stratified and analyzed in 4 different Arms, one Normative and three Pathologies, according to a prospective statistical plan and based on the prevalence of common pathological conditions in each age group; this will be determined by analysis of the literature, analysis of study demographics and concomitant diseases, and on the PI and/or sponsor's discretion. Suggested enrollment numbers for the different age groups and different Arms are:
Condition
  • Early Onset Alzheimer Disease
  • Mild Cognitive Impairment
  • Depression
  • Aging
Intervention Not Provided
Study Groups/Cohorts
  • Healthy aging
    Subjects meeting criteria for healthy aging No intervention administered
  • Early Alzheimer Disease
    Subjects meeting criteria for Early Alzheimer Disease No intervention administered
  • Depression
    Subjects meeting criteria for Depression No intervention administered
  • MCI-Mild Cognitive Impairment
    Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

For ALL arms:

Inclusion Criteria:

  • Currently resides in The Villages community
  • Age 50-years and above.
  • Able to speak, read and understand English
  • Willingness to participate and able to give informed consent.
  • If corrected vision: only Glasses should be used during the study testing

Exclusion Criteria:

  • Currently with lice or open wounds on scalp.
  • Any CNS neurologic disorder
  • Significant sensory deficits.
  • Use of a hearing aid that occupies the ear canal
  • Any neuropsychological disorders
  • History of special education
  • Substance abuse in the last 3 months
  • History of any clinically significant brain trauma as determined by the investigator.
  • Clinically diagnosed with a concussion in the past year.

For Arm 1 Healthy

Inclusion Criteria:

  • BDI score <14
  • Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR,
  • MMSE score ≥25

Exclusion Criteria:

  • Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
  • Any psychiatric disorder,
  • History of any medication affecting CNS within the last 3 months

For Arm 2 Early Alzheimer's Disease

Inclusion Criteria:

  • BDI score <14
  • Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR, as determined by clinical evaluation by a research clinician and the Mini International Neuropsychiatric Interview (MINI).
  • MMSE score <24
  • MoCA<20
  • Presence of an early and significant episodic memory impairment

Exclusion Criteria:

  • Any chronic disease or condition other than current pathology
  • Any other psychiatric disorder
  • CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.

For Arm 3 Depression

Inclusion Criteria:

  • BDI score >14
  • Subjects meeting full diagnostic criteria for MDD without psychotic features per the DSM IV-TR
  • HAM-D 17-item: Total score of 16 or higher at visit 1.

Exclusion Criteria:

  • Any chronic disease or condition other than current pathology
  • Any psychiatric disorder other than Depression
  • CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.

For Arm 4 Mild Cognitive Impairment

Inclusion Criteria:

  • BDI score <14
  • Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR
  • MMSE scores according to Number of years of Education:

MMSE score Years of Education 17-18 ≤6 20-21 7-8 23-24 ≤10

-20<MoCA score >26

Exclusion Criteria:

  • Any chronic disease or condition other than current pathology
  • Any other psychiatric disorder
  • CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Carla VandeWeerd, PhD 352-674-8859 research@thevillageshealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02875496
Other Study ID Numbers ELM-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ElMindA Ltd
Study Sponsor ElMindA Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Jeffrey Lowenkron, MD Chief Medical Officer, The Villages Health
Principal Investigator: Carla VandeWeerd, PhD Director of Research, The Villages Health
PRS Account ElMindA Ltd
Verification Date January 2018