Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain

NCT ID: NCT02875496

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2022-12-31

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.

Conditions

Early Onset Alzheimer Disease; Mild Cognitive Impairment; Depression; Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy aging

Subjects meeting criteria for healthy aging No intervention administered

No interventions assigned to this group

Early Alzheimer Disease

Subjects meeting criteria for Early Alzheimer Disease No intervention administered

No interventions assigned to this group

Depression

Subjects meeting criteria for Depression No intervention administered

No interventions assigned to this group

MCI-Mild Cognitive Impairment

Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered

No interventions assigned to this group

General Arm

Subjects not meeting criteria for any of the other arms (Healthy, Early Alzheimer's, Depression, or MCI)

No interventions assigned to this group

Eligibility Criteria

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

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

• 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

• 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.

• 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

• 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

• 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

• 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

• 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

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ElMindA Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Lowenkron, MD

Role: PRINCIPAL_INVESTIGATOR

Chief Medical Officer, The Villages Health

Carla VandeWeerd, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Research, The Villages Health

Locations

The Villages Health

The Villages, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla VandeWeerd, PhD

Role: CONTACT

research@thevillageshealth.com

352-674-8859

Facility Contacts

Carla VanderWeerd, PhD

Role: primary

research@thevillageshealth.com

352-674-8859

Other Identifiers

ELM-26

Identifier Type: -

Identifier Source: org_study_id