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NCT Number: NCT04699786

Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies

This is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of Alzheimer disease dementia to participants without memory or thinking problems of the Knight Alzheimer Disease Research Center at Washington University in St. Louis.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Dementia of Alzheimer Type Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

All participants without memory or thinking problems in a longitudinal observational cohort of aging (Memory and Aging Project) will be offered a five-year Alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year Alzheimer disease dementia risk estimate. Using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (Arm A/C) or one year (Arm B/D) after informed consent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current Knight ADRC participants who had their clinical assessment in the previous year.
  • Minimum age of 65 years old
  • Participant must be classified as cognitively normal (CDR® = 0) at their last clinical assessment.
  • Participant has either recent research brain MRI and amyloid PET scan results, or recent plasma amyloid measurements (ideally within the past two years, but up to five years will be acceptable due to COVID-19-related delays).
  • Participant has genetic research results available including APOE status.
  • Participant is currently consented to be contacted for other research opportunities through the Knight ADRC.

Exclusion criteria

  • There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.

Treatment and study plan

Arm A , Arm B, Arm C, & Arm D

Other

All arms will receive the same intervention, but at different time points. All arms will be offered the option to learn their research results in personalized five-year risk estimate of getting Alzheimer disease dementia. Arms A & C participants will receive their risk estimate about two weeks after consent is signed and Arms B& D will receive their risk estimate about one year after consent is signed. The risk estimate returned to participants is based on research results from individual genotyping results, imaging or plasma amyloid testing & demographic characteristics. All arms will complete psychosocial and cognitive testing. Also, surveys used in this study will ask about participants' experiences and feelings after learning their risk estimate. All arms will receive follow up calls at one week post disclosure of the risk estimate and surveys two, six, and twelve months post disclosure. Arms A & C will have extra surveys at twenty-four months post disclosure.

Primary outcomes

  1. Change in Geriatric Depression Scale (GDS)

    Time frame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. GDS is also measured at the time of informed consent.

    GDS is a questionnaire that screens for depression in older adults. It's a self-report tool that asks yes or no questions about how a person has been feeling over the past week.

  2. Change in Clinical Dementia Rating sum of box score (CDR-SB)

    Time frame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.

    Subjective measure of dementia determined as part of clinical assessment.

  3. Change in cognitive composite score

    Time frame: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.

    Objective measure of cognitive functioning.

Secondary outcomes

  1. Impact of Events Scale Revised (IES-R)

    Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.

    A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.

  2. Decision Regret Scale

    Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.

    The Decision Regret Scale measures "distress or remorse" after receiving research results.

  3. Self- Report Heath Care Utilization

    Time frame: At consent, 6, 12 and 24 months post-disclosure of risk estimate

    This scale measures self-reported health care utilization that indicates both patients' health and their ability to self-manage their condition.

  4. Understanding of Research Results

    Time frame: 2, 12 and 24 months post-disclosure of risk estimate.

    The scale measures participant's comprehension of their research results.

  5. Patient Assessment of Communication Effectiveness

    Time frame: 2 months post-disclosure of risk estimate.

    This scale investigates participants' perspectives on communication and to measure how well the research team communicated research results to participants

  6. Lifestyle/Health Behavior Change

    Time frame: 6, 12 and 24 months post-disclosure of risk estimate.

    This scale gauges self-reported preparedness of future health and end of life situations.

  7. AD-Related Distress

    Time frame: At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.

    This scale measures participants' self-reported anxiety (psychological impact) about developing AD dementia.

  8. Future Time Perspective

    Time frame: At consent, 12 and 24 months post-disclosure of risk estimate.

    This scale measures how participants' feel about future events and their self-reported agreement or disagreement with the future events.

  9. Modified Social Impact Scale

    Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.

    This scale assesses whether participant's self-image after learning research results indicating risk of developing AD dementia is affected by notions of stigma.

  10. Views Regarding Research

    Time frame: At consent, 6 and 12 months post-disclosure of risk estimate.

    This scale assesses the impact of learning research results on attitudes towards research participation.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial

Acronym: WeSHARE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 7, 2021
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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