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

ElMindA

Status

Unknown

Conditions

Aging

Mild Cognitive Impairment

Early Onset Alzheimer Disease

Depression

Study type

Observational

Funder types

Industry

Identifiers

NCT02875496

ELM-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.