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CognitionNCT07763392

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

An observational study of Cognition and Cognition Disorders, run by The Neurology Center of Southern California at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Cognition, Cognition Disorders, Cognition - Other
What is being tested?
Voice-based Cognitive Testing
How many people
1,000 participants
Where
1 siteUnited States
Study dates
23 Mar 2026to 23 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Cognitively normal adults from 18-100

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gregory Sahagian, MD contact

760-631-3000

research@intraneuron.com

United States1 site, 1 recruiting
  • The Neurology Center of Southern California

    Carlsbad, California, 92011

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read more

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.

Being tested
Voice-based Cognitive Testing
Keywords
Memory, Cognition, Dementia, Alzheimer's Disease, Normal
Medical subject headings
Cognition Disorders, Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voice-based Cognitive TestingDiagnostic test

    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.

Study groups in NCT07763392
Study groupRoleWhat they receive
Ages 18-29Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 30-39Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 40-49Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 50-59Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 60-69Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 70-79Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 80-89Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing
Ages 90-100Not described
Receives: Diagnostic Test: Voice-based Cognitive Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of normative reference values

    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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start23 Mar 2026
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion23 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07763392
Sponsor's protocol ID
Intra001
Other IDs
1407599, https://www.memoryexam.com/job
Status last verified
Aug 2026
First submitted
8 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cognition and Cognition Disorders, run by The Neurology Center of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory Sahagian, MD (760-631-3000, research@intraneuron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of normative reference values (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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