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Alzheimer DiseaseeSMARTERNCT06459583

Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results

A study testing eHealth Platform and Videoconference Telehealth Platform in people with Alzheimer Disease, run by Banner Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
eHealth Platform and Videoconference Telehealth Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
681 participants
Where
2 sitesUnited States
Study dates
10 Oct 2024to 7 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Access to the internet and an internet-enabled device.
  • Participant is able to provide informed consent as shown by correctly answering questions administered by the study coordinator during the electronic consenting process that assess understanding of consent form content.
  • Participant is willing and has the ability to fully comply with study procedures defined in this protocol.
  • Written and spoken fluency in the English.
  • Participant agrees to undergo a blood draw for collection of a blood sample for future testing and repository storage.

Who cannot join

  • Participant reports prior knowledge of APOE genotype.
  • Lack of psychological readiness to receive AD gene and biomarker information as indicated by:
  • obtaining a score of 10 or greater on the Patient Health Questionnaire - 9 (PHQ-9) AND/OR
  • responding yes on any of the suicidal ideation questions extracted from the abbreviated Columbia Suicide Severity Scale (C-SSRS) or AD Specific Suicidality Questions.
  • Presence of current major psychiatric illness, e.g., psychosis, bipolar disorder, PTSD
  • Communication difficulties such as:
  • Uncorrected or uncompensated hearing and/or vision impairment.
  • Uncorrected or uncompensated speech defects.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Accellacare Clinical Research Site 01

    Bristol, Tennessee, 37620

  • Accellacare Clinical Research Site 02

    Mt. Pleasant, South Carolina, 29464

Other trials in United States

About this study

This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

Read the detailed description

This is a randomized trial to evaluate self-directed scalable eHealth methods for communicating Alzheimer's gene and biomarker results, as well as characterize the clinical impacts of learning this information on the participant. All participants in the study will be randomized to receive their Alzheimer's gene and biomarker results either via person-mediated telehealth videoconference visit with a healthcare provider or by eHealth platform. A permuted block design will be used for randomization, and we will stratify by sex and apolipoprotein E (APOE) genotype.

Participants randomized to the eHealth arm will be offered either the ADWebPortal or ADChatbot but can switch between platforms or schedule a virtual appointment to speak with a healthcare provider at any point. Use of the pre-disclosure education platforms will be tracked. A HIPAA compliant telehealth application will be used for the person-mediated telehealth videoconference visits and sessions will be recorded.

Potential participants will be identified from the GeneMatch program. Study management and participation will be decentralized. Confirmation of eligibility and consent of potential participants will be completed remotely by a decentralized study team. Procedures requiring physical attendance (e.g., blood draw) will be completed remotely using mobile health services.

Being tested
eHealth Platform, Videoconference Telehealth Platform
Keywords
APOE
Medical subject headings
Alzheimer Disease

What participants receive

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

  • eHealth PlatformOther

    The eHealth Platform consists of the ADWebPortal and ADChatbot for receiving Alzheimer's-related test results

  • Videoconference Telehealth PlatformOther

    Participants will have a video telehealth visit with a healthcare provider to receive Alzheimer's-related test results

Study groups in NCT06459583
Study groupRoleWhat they receive
eHealth platformExperimentalThe eHealth platform consists of the self-directed web-portal (ADWebPortal) and chatbot (ADChatbot) to receive their Alzheimer's-related test results. Participants randomized to this arm can switch between the two or schedule a virtual appointment with a healthcare provider.
Receives: Other: eHealth Platform
Videoconference telehealthActive comparatorThe videoconference telehealth platform consists of remote visit(s) with a healthcare provider to receive their Alzheimer's-related test results.
Receives: Other: Videoconference Telehealth Platform

What is being measured

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

  1. Anxiety as measured by the PROMIS Anxiety scale

    Anxiety scale

    Measured: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

  2. Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale

    Knowledge of Genetic Disease scale

    Measured: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

  3. Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale

    Disease-specific distress scale

    Measured: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

Secondary outcomes (6)

  1. Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)

    Depression scale

    Measured: 0-7 days, 6 weeks, 6 months

  2. Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale

    Psychological wellbeing scale

    Measured: 6 months

  3. Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study

    Perceived risk of Alzheimer's scale

    Measured: 0-7 days, 6 weeks, 6 months

  4. Impact of disclosure as measured by the 16-item IGT-AD scale

    Impact of genetic testing for Alzheimer's disease (IGT-AD) scale

    Measured: 0-7 days, 6 weeks, 6 months

  5. Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument

    Subjective cognitive concerns scale

    Measured: 6 months

  6. Stigma as measured by the 6-item Stigma Impact Scale

    Stigma scale

    Measured: 0-7 days, 6 weeks, 6 months

Timeline

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

  1. First posted14 Jun 2024
  2. Study start10 Oct 2024
  3. Primary completion7 Nov 2025
  4. Study completion7 Nov 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459583
Sponsor's protocol ID
API-0001
Other IDs
R01AG058468
Acronym
eSMARTER
Status last verified
Dec 2025
First submitted
23 May 2024
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Trial dataset and biological samples will be shared with qualified investigators

Publications

  • Erickson CM, Langlois CM, Wood EM, Mim R, Howe S, Ofidis D, Egleston BL, Harkins K, Largent EA, Roberts JS, Reiman EM, Denkinger M, Ashton NJ, Karlawish J, Bradbury AR, Langbaum JB. Evaluation of self-mediated alternatives for risk testing education and return of results (eSMARTER) study: A randomized study of methods for returning APOE and pTau-217 results. Alzheimers Dement (N Y). 2025 Nov 16;11(4):e70177. doi: 10.1002/trc2.70177. eCollection 2025 Oct-Dec.

    PubMed 41250770

  • Langbaum JB, Erickson CM, Langlois C, Wood EM, Egleston BL, Harkins K, Mim R, John S, Brown C, Brown S, Howe S, Cacioppo C, Eppelmann L, Enos J, Salata H, DeSantiago D, Largent EA, Reiman EM, Denkinger MN, Ashton NJ, Roberts JS, Karlawish J, Bradbury AR. Returning APOE and pTau-217 Results: the eSMARTER Randomized Noninferiority Clinical Trial. medRxiv [Preprint]. 2026 Sep 1:2026.08.27.26361535. doi: 10.64898/2026.08.27.26361535.

    PubMed 42922812

Questions about this trial

What is this clinical trial studying?

A study testing eHealth Platform and Videoconference Telehealth Platform in people with Alzheimer Disease, run by Banner Health at 2 sites 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 8 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: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety as measured by the PROMIS Anxiety scale (time frame: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06459583, which also lists 2 linked publications.

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 14 Jan 2026.

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