Recruiting

Observational Study

Sponsor:

ElMindA Ltd

Code:

NCT02875496

Conditions

Early Onset Alzheimer Disease

Mild Cognitive Impairment

Depression

Aging

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT02875496

Start date

Aug, 2016

Status verified date

Nov, 2019

Completion date

Dec, 2022

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • Developing a BNA database for healthy aging population. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

The Villages Health

Recruiting

The Villages, Florida, United States, 32162

Contacts

Principal Investigator:

Jeffrey Lowenkron, MD

More Information

Sponsor

ElMindA Ltd

Last update posted

Nov 27, 2019

Last verified

Nov, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ElMindA Ltd on 2019-11-27.