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Establishing Normal Cognitive Test Scores for Adults Using a Voice-Enabled Digital Testing Platform Across the Lifespan

13. august 2026 opdateret af: The Neurology Center of Southern California

Establishment of Age-, Sex-, and Education-Stratified Normative Data for a Fully Digital Voice-Recognized Neurocognitive Testing Platform in Adults Aged 18-100 Years

Trial weblink: https://www.memoryexam.com/job/norms/

Participants enrolled in this study will complete a single-session, non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the study is to establish normative cognitive performance data from healthy adults aged 18-100 years and develop age-, sex-, and education-adjusted reference values for the digital assessment platform. This is an observational study and does not involve any therapeutic intervention, investigational treatment, or alteration of routine medical care.

Following electronic informed consent, participants will complete a standardized screening questionnaire to determine eligibility. The questionnaire collects demographic information, education, English language proficiency, medical and neurological history, psychiatric history, medication use, substance use, sleep history, and self-reported cognitive concerns. Standardized mood screening instruments (PHQ-9 and GAD-7) are also administered. Individuals meeting predefined exclusion criteria that could significantly influence cognitive performance will not be included in the normative dataset.

Eligible participants will then complete a digital cognitive assessment battery using standardized visual and auditory instructions. The platform utilizes automated voice-recognition technology to capture spoken responses and standardized algorithms to score performance, eliminating the need for examiner scoring and ensuring consistent administration across participants. Total study participation, including consent, screening, and testing, is approximately 30 to 45 minutes.

The cognitive battery evaluates multiple cognitive domains commonly assessed during neuropsychological examinations. Language abilities are assessed through phonemic and semantic verbal fluency tasks, measuring the ability to rapidly generate words within specified categories. Confrontation naming is evaluated using digitally presented images that participants identify verbally. Learning and memory are assessed through immediate and delayed verbal recall tasks, including recognition memory measures. Attention and working memory are evaluated using forward and backward digit span tasks. Executive functioning and attention are further assessed using a brief computerized problem-solving task. Equivalent alternate versions of selected tasks may be administered to minimize practice effects while measuring the same cognitive domains. All assessments are brief, non-invasive, and completed using spoken responses.

The platform automatically records participant responses, response timing, and scoring metrics. Voice recordings are collected solely to support automated scoring and quality assurance. All electronic data are transmitted using encrypted connections and stored within HIPAA-aligned cloud infrastructure. Personally identifiable information is stored separately from cognitive performance data using unique study identification numbers, and only authorized study personnel have access to identifiable information. De-identified data will be used to generate normative reference values.

A subset of approximately 100 participants may be invited to complete a second assessment 2-4 weeks after the initial visit to evaluate test-retest reliability. Participation in this follow-up assessment is voluntary.

Participants will not receive diagnostic results or individualized interpretations of their performance because the study is intended solely to establish normative reference data. If responses on the PHQ-9 suggest potential acute self-harm risk, the platform will provide crisis resources and notify the study team in accordance with the study safety procedures.

The primary outcome of the study is the development of age-, sex-, and education-adjusted normative reference values for the digital cognitive assessment platform, supporting standardized interpretation of future assessments in clinical and research settings.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Forenede Stater
    • California
      • Carlsbad, California, Forenede Stater, 92011
        • Rekruttering
        • The Neurology Center of Southern California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Cognitively normal adults from 18-100

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 100 years at the time of enrollment.
  • Able to read, speak, and understand English sufficiently to complete all study procedures.
  • Able and willing to provide informed consent.
  • Adequate hearing, speech, and vision (with corrective devices if needed) to complete computerized voice-recognition cognitive testing.
  • Able to independently complete the digital cognitive assessment using a computer, tablet, or smartphone with internet access (or at a supervised study site if applicable).

Exclusion Criteria:

  • Known Cognitive Impairment Self-reported or previously diagnosed cognitive impairment, memory disorder, mild cognitive impairment, or dementia.
  • Neurological Disease or Brain Injury History of a neurological condition or brain injury that, in the opinion of the investigator, may adversely affect cognitive performance.
  • Psychiatric Illness Current or untreated psychiatric illness that may significantly influence cognitive testing performance.
  • Substance Use or Cognitive-Impacting Medications Current use of substances or medications known to significantly impair cognition or recent substance use that could affect test validity.
  • Sensory or Communication Limitations Inadequate English proficiency or speech, hearing, or visual impairments that would prevent valid completion of the digital cognitive assessment.
  • Functional or Medical Conditions Affecting Cognition Medical conditions or functional impairments that, in the opinion of the investigator, may interfere with accurate assessment of normal cognitive performance.
  • Investigator Discretion Any other condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety, study compliance, or the validity of the normative dataset.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ages 18-29
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 30-39
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 40-49
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 50-59
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 60-69
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 70-79
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 80-89
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.
Ages 90-100
Diagnostisk test: Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Development of normative reference values
Tidsramme: 30 minutes
These normative values constitute the primary scientific outcome of the study and will serve as the reference database for interpretation of future individual assessments. This aligns with the protocol's objective to establish age-, sex-, and education-stratified normative data for the digital cognitive platform.
30 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
The Neurology Center of Southern California

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Intraneuron

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
23. marts 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
23. oktober 2026

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
23. marts 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
8. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
8. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
17. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
13. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • Intra001
  • 1407599 (Anden identifikator: WCG IRB)
  • https://www.memoryexam.com/job (Anden identifikator: Intraneuron, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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