NCT06459583Completed
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 681 (actual)
- First submitted
- 23 May 2024
- Start date
- 10 Oct 2024
- Primary completion date
- 7 Nov 2025
- Lead sponsor
- Banner Health
- Diseases
- Alzheimer disease
- NCT number
- NCT06459583
What you commit to
- Study type: Interventional
- Participants enrolled: 681
- From 10 Oct 2024 to the primary completion date, 7 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant reports prior knowledge of APOE genotype.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Accellacare Clinical Research Site 01 Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| Accellacare Clinical Research Site 02 Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
Related publications
- Returning APOE and pTau-217 Results: the eSMARTER Randomized Noninferiority Clinical Trial.medRxiv · 2026 · PMID 42922812
This page is information, not medical advice. Discuss any trial with your doctor.