Alzheimer DiseaseWeSHARENCT04699786
Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies
A study testing Arm A , Arm B, Arm C, & Arm D in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia of Alzheimer Type
- What is being tested?
- Arm A , Arm B, Arm C, & Arm D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to Jun 2026
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Being tested
- Arm A , Arm B, Arm C, & Arm D
- Keywords
- Dementia, Alzheimer disease dementia, genetics, neuroimaging
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A , Arm B, Arm C, & Arm DOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Participants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm. Receives: Other: Arm A , Arm B, Arm C, & Arm D |
| Arm B | Active comparator | Participants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm. Receives: Other: Arm A , Arm B, Arm C, & Arm D |
| Arm C | Active comparator | Participants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm. Receives: Other: Arm A , Arm B, Arm C, & Arm D |
| Arm D | Active comparator | Participants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm. Receives: Other: Arm A , Arm B, Arm C, & Arm D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Geriatric Depression Scale (GDS)
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.
Measured: 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.
Change in Clinical Dementia Rating sum of box score (CDR-SB)
Subjective measure of dementia determined as part of clinical assessment.
Measured: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Change in cognitive composite score
Objective measure of cognitive functioning.
Measured: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Secondary outcomes (10)
Impact of Events Scale Revised (IES-R)
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.
Measured: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Decision Regret Scale
The Decision Regret Scale measures "distress or remorse" after receiving research results.
Measured: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Self- Report Heath Care Utilization
This scale measures self-reported health care utilization that indicates both patients' health and their ability to self-manage their condition.
Measured: At consent, 6, 12 and 24 months post-disclosure of risk estimate
Understanding of Research Results
The scale measures participant's comprehension of their research results.
Measured: 2, 12 and 24 months post-disclosure of risk estimate.
Patient Assessment of Communication Effectiveness
This scale investigates participants' perspectives on communication and to measure how well the research team communicated research results to participants
Measured: 2 months post-disclosure of risk estimate.
Lifestyle/Health Behavior Change
This scale gauges self-reported preparedness of future health and end of life situations.
Measured: 6, 12 and 24 months post-disclosure of risk estimate.
AD-Related Distress
This scale measures participants' self-reported anxiety (psychological impact) about developing AD dementia.
Measured: At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.
Future Time Perspective
This scale measures how participants' feel about future events and their self-reported agreement or disagreement with the future events.
Measured: At consent, 12 and 24 months post-disclosure of risk estimate.
Modified Social Impact Scale
This scale assesses whether participant's self-image after learning research results indicating risk of developing AD dementia is affected by notions of stigma.
Measured: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Views Regarding Research
This scale assesses the impact of learning research results on attitudes towards research participation.
Measured: At consent, 6 and 12 months post-disclosure of risk estimate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start19 Feb 2021
- Primary completion10 Jun 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Hartz, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699786
- Sponsor's protocol ID
- 202011119
- Acronym
- WeSHARE
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
Publications
Hartz SM, Jackson S, Benzinger TLS, Bierut L, Evans A, Goswami S, Gordon BA, Hassenstaab J, Hayibor L, Linnenbringer E, Morris JC, Moulder KL, Oliver A, Sun L, Schindler SE, Xiong C, Mozersky J. No cognitive or psychological impact from returning research Alzheimer disease biomarkers: A delayed-start, noninferiority, randomized clinical trial. medRxiv [Preprint]. 2026 Jun 10:2026.05.22.26353881. doi: 10.64898/2026.05.22.26353881.
PubMed 42326827Hartz SM, Goswami S, Oliver A, Evans A, Jackson S, Linnenbringer E, Moulder KM, Morris JC, Mozersky J. What is the psychological and cognitive impact of returning Alzheimer disease dementia research results to healthy research participants? a delayed-start randomised clinical trial protocol for the WeSHARE study (Washington University study of having Alzheimer disease research results explained). BMJ Open. 2026 Jan 6;16(1):e099970. doi: 10.1136/bmjopen-2025-099970.
PubMed 41500647
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04699786
- Acronym / sponsor ID
- WeSHARE / 202011119
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Keywords
- Dementia, Alzheimer disease dementia, genetics, neuroimaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Other: Arm A , Arm B, Arm C, & Arm DParticipants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm. |
| Arm B | Active comparator | Other: Arm A , Arm B, Arm C, & Arm DParticipants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm. |
| Arm C | Active comparator | Other: Arm A , Arm B, Arm C, & Arm DParticipants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm. |
| Arm D | Active comparator | Other: Arm A , Arm B, Arm C, & Arm DParticipants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A , Arm B, Arm C, & Arm DAll 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. | Other | Arm A, Arm B, Arm C, Arm D |
Primary outcome
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.
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.
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.
10 secondary outcomes
Impact of Events Scale Revised (IES-R)
Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Decision Regret Scale
Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Self- Report Heath Care Utilization
Time frame: At consent, 6, 12 and 24 months post-disclosure of risk estimate
Understanding of Research Results
Time frame: 2, 12 and 24 months post-disclosure of risk estimate.
Patient Assessment of Communication Effectiveness
Time frame: 2 months post-disclosure of risk estimate.
Lifestyle/Health Behavior Change
Time frame: 6, 12 and 24 months post-disclosure of risk estimate.
AD-Related Distress
Time frame: At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.
Future Time Perspective
Time frame: At consent, 12 and 24 months post-disclosure of risk estimate.
Modified Social Impact Scale
Time frame: 2, 6, 12 and 24 months post-disclosure of risk estimate.
Views Regarding Research
Time frame: At consent, 6 and 12 months post-disclosure of risk estimate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42326827Hartz SM, Jackson S, Benzinger TLS, Bierut L, Evans A, Goswami S, Gordon BA, Hassenstaab J, Hayibor L, Linnenbringer E, Morris JC, Moulder KL, Oliver A, Sun L, Schindler SE, Xiong C, Mozersky J. No cognitive or psychological impact from returning research Alzheimer disease biomarkers: A delayed-start, noninferiority, randomized clinical trial. medRxiv [Preprint]. 2026 Jun 10:2026.05.22.26353881. doi: 10.64898/2026.05.22.26353881.
- Derived from this study: PubMed 41500647Hartz SM, Goswami S, Oliver A, Evans A, Jackson S, Linnenbringer E, Moulder KM, Morris JC, Mozersky J. What is the psychological and cognitive impact of returning Alzheimer disease dementia research results to healthy research participants? a delayed-start randomised clinical trial protocol for the WeSHARE study (Washington University study of having Alzheimer disease research results explained). BMJ Open. 2026 Jan 6;16(1):e099970. doi: 10.1136/bmjopen-2025-099970.
- Individual participant dataSharing planned: Yes. Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hartz, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A , Arm B, Arm C, & Arm D in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Washington University School of Medicine 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 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?
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?
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.). 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 NCT04699786, 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 10 Mar 2026.