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

Status unconfirmed

Conditions studied: Early Onset Alzheimer Disease, Mild Cognitive Impairment, Depression, Aging

In brief

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.

Key facts

Study ID

NCT02875496

Run by

ElMindA Ltd

People needed

2000

Starts

2016-08-01

Expected to finish

2022-12-01

Last updated by the study team

2019-11-27

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• The Villages Health — The Villages, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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