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

25 november 2019 uppdaterad av: ElMindA Ltd

Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain: Brain Network Activation Analysis (BNA™) for the Adult and Elderly Population Using Evoked Response Potentials

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

2000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • The Villages, Florida, Förenta staterna, 32162
        • Rekrytering
        • The Villages Health
        • Kontakt:
        • Huvudutredare:
          • Jeffrey Lowenkron, MD
        • Huvudutredare:
          • Carla VanderWeerd, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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:

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Developing a BNA database for healthy aging population.
Tidsram: 2 years
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Jeffrey Lowenkron, MD, Chief Medical Officer, The Villages Health
  • Huvudutredare: Carla VandeWeerd, PhD, Director of Research, The Villages Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2016

Primärt slutförande (Förväntat)

1 augusti 2022

Avslutad studie (Förväntat)

1 december 2022

Studieregistreringsdatum

Först inskickad

4 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2016

Första postat (Uppskatta)

23 augusti 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 november 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

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