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

NCT02875496 | Unknown

• 1 other identifier: ELM-26
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Developing a BNA database for healthy aging population.

  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.

  2 years

Study Arms (5)

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

General Arm

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• 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

You may not qualify if:

• 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
• BDI score \<14
• Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR,
• MMSE score ≥25
• Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
• Any psychiatric disorder,

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

The Villages Health

The Villages, Florida, 32162, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jeffrey Lowenkron, MD

  Chief Medical Officer, The Villages Health

  PRINCIPAL INVESTIGATOR

• Carla VandeWeerd, PhD

  Director of Research, The Villages Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla VandeWeerd, PhD

CONTACT

352-674-8859; research@thevillageshealth.com

Study Design

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

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 23, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)