Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial
Study on returning Alzheimer's risk results to healthy older adults
Plain English Summary
Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies is a Not Applicable clinical trial sponsored by Washington University School of Medicine studying Alzheimer Disease, Dementia of Alzheimer Type. This study tests how people feel and react when they are told their estimated risk of developing Alzheimer's disease dementia. It is for healthy individuals aged 65 and older who are already part of a research study at Washington University. Participants will be offered the chance to learn their 5-year risk estimate for Alzheimer's dementia, based on their research data. The alternative is not knowing this specific risk information. The trial aims to enroll 450 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 65 or older and currently a participant in a Knight ADRC study at Washington University. You must have had a recent cognitive assessment showing you are cognitively normal. You need to have recent research results from brain scans (MRI, PET) or blood tests (plasma amyloid), and genetic information (APOE status). You must be willing to be contacted for research opportunities. This trial is studying Alzheimer Disease, Dementia of Alzheimer Type, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure changes in mood (depression), cognitive function, and how participants cope with the information, to understand the emotional and mental impact of receiving a personalized risk The specific primary outcome measures are: Change in Geriatric Depression Scale (GDS) (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) (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.); Change in cognitive composite score (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the important question of how best to share potentially sensitive genetic and research findings about Alzheimer's risk with individuals who are currently healthy, filling a gap in This research targets Alzheimer Disease, Dementia of Alzheimer Type, where improved treatment options are needed.
Investor Insight
This trial explores the ethical and psychological aspects of returning genetic and biomarker data related to Alzheimer's risk, a growing area of interest as diagnostic tools improve, potentially impac
Is This Trial Right for Me?
Ask your doctor about what the risk estimate means for you and your family. Consider discussing the potential emotional impact of receiving this information with a healthcare professional or counselor. Participation involves receiving your risk estimate at different times depending on your assigned group, and then completing questionnaires over time. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 450 participants
Interventions
- OTHER: Arm A , Arm B, Arm C, & Arm D — 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 geno
Primary Outcomes
- Change in Geriatric Depression Scale (GDS) (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) (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.)
- Change in cognitive composite score (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.)
Secondary Outcomes
- Impact of Events Scale Revised (IES-R) (2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Decision Regret Scale (2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Self- Report Heath Care Utilization (At consent, 6, 12 and 24 months post-disclosure of risk estimate)
- Understanding of Research Results (2, 12 and 24 months post-disclosure of risk estimate.)
- Patient Assessment of Communication Effectiveness (2 months post-disclosure of risk estimate.)
Full Eligibility Criteria
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.
Trial Locations
- Washington University School of Medicine, St Louis, Missouri, United States
Frequently Asked Questions
What is clinical trial NCT04699786?
NCT04699786 is a Not Applicable INTERVENTIONAL study titled "Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies." It is currently active, not recruiting and is sponsored by Washington University School of Medicine. The trial targets enrollment of 450 participants.
What conditions does NCT04699786 study?
This trial investigates treatments for Alzheimer Disease, Dementia of Alzheimer Type. The primary condition under study is Alzheimer Disease.
What treatments are being tested in NCT04699786?
The interventions being studied include: 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 geno
What does Not Applicable mean for NCT04699786?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04699786?
This trial is currently "Active, Not Recruiting." It started on 2021-02-19. The estimated completion date is 2026-06.
Who is sponsoring NCT04699786?
NCT04699786 is sponsored by Washington University School of Medicine. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04699786?
The trial aims to enroll 450 participants. The trial status is active, not recruiting.
How is NCT04699786 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04699786?
The primary outcome measures are: Change in Geriatric Depression Scale (GDS) (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) (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.); Change in cognitive composite score (Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04699786 being conducted?
This trial is being conducted at 1 site, including St Louis, Missouri (United States).
Where can I find official information about NCT04699786?
The official record for NCT04699786 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04699786. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04699786 testing in simple terms?
This study tests how people feel and react when they are told their estimated risk of developing Alzheimer's disease dementia. It is for healthy individuals aged 65 and older who are already part of a research study at Washington University.
Why is this trial significant?
This trial addresses the important question of how best to share potentially sensitive genetic and research findings about Alzheimer's risk with individuals who are currently healthy, filling a gap in
What are the potential risks of participating in NCT04699786?
Potential emotional distress, anxiety, or sadness related to learning about your risk for Alzheimer's disease. Worry about the accuracy of the risk estimate or its implications for your future. The information may cause you to change your life plans or healthcare decisions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04699786?
Ask your doctor about what the risk estimate means for you and your family. Consider discussing the potential emotional impact of receiving this information with a healthcare professional or counselor. Participation involves receiving your risk estimate at different times depending on your assigned group, and then completing questionnaires over time. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04699786 signal from an investment perspective?
This trial explores the ethical and psychological aspects of returning genetic and biomarker data related to Alzheimer's risk, a growing area of interest as diagnostic tools improve, potentially impac This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be offered the chance to learn their 5-year risk estimate for Alzheimer's dementia, based on their research data. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.