Trial reportAnnals of internal medicine2016
Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial.
Trial report in Annals of internal medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 28 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Risk Evaluation and Education for Alzheimer's Disease
Pre-Clinical Alzheimer's (ALZ) Diagnosis (PCD) = Optimum Outcomes (OO)
Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) as a Pre-Clinical or Pro-Dromal Alzheimers Diagnosis (Prognosis) for Optimum Outcomes
Who cites it
28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Return of individual research results from genomic research: A systematic review of stakeholder perspectives.PloS one · 2021Pooled it
- Impact of SLCO1B1 Pharmacogenetic Testing on Patient and Healthcare Outcomes: A Systematic Review.Clinical pharmacology and therapeutics · 2019Pooled it
- Clinical implications of APOE genotyping for late-onset Alzheimer's disease (LOAD) risk estimation: a review of the literature.Journal of neural transmission (Vienna, Austria : 1996) · 2019Pooled it
- Behavioral impact of return of genetic test results for complex disease: Systematic review and meta-analysis.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2018Pooled it
- Tele-Genetic Versus Onsite Counseling for APOE Disclosure: A 6-Month Study of Empowerment, Psychological Distress, and Behavioral Outcomes in Cognitively Diverse Individuals.The journal of gene medicine · 2025Trial
- Effects of participation in a U.S. trial of newborn genomic sequencing on parents at risk for depression.Journal of genetic counseling · 2022Trial
- Short-term costs of integrating whole-genome sequencing into primary care and cardiology settings: a pilot randomized trial.Genetics in medicine : official journal of the American College of Medical Genetics · 2018Trial
- Disclosure of Personalized Rheumatoid Arthritis Risk Using Genetics, Biomarkers, and Lifestyle Factors to Motivate Health Behavior Improvements: A Randomized Controlled Trial.Arthritis care & research · 2018Trial
- A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone.Genetics in medicine : official journal of the American College of Medical Genetics · 2018Trial
- Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study.Patient education and counseling · 2017Trial
- A randomized trial Examining The Impact Of Communicating Genetic And Lifestyle Risks For Obesity.Obesity (Silver Spring, Md.) · 2016Trial
- Now is the time: the need to update guidance to expand access toFrontiers in dementia · 2026Article
- Pharmacogenetics or predictive genetics? APOE testing blurs the lines.Frontiers in pharmacology · 2025Review
- The Return of Biomarker Results in Research: Balancing Complexity, Precision, and Ethical Responsibility.Journal of Alzheimer's disease : JAD · 2024Review
- Public perspective on medications to delay Alzheimer's disease symptoms.Journal of genetic counseling · 2023Article
- Behavioral and psychological impact of genome sequencing: a pilot randomized trial of primary care and cardiology patients.NPJ genomic medicine · 2021Article
- A scoping review of social and behavioral science research to translate genomic discoveries into population health impact.Translational behavioral medicine · 2021Article
- Beyond cardiovascular medicine: potential future uses of icosapent ethyl.European heart journal supplements : journal of the European Society of Cardiology · 2020Article
- Predictive Genetic Counseling for Neurodegenerative Diseases: Past, Present, and Future.Cold Spring Harbor perspectives in medicine · 2020Review
- Genetic testing for neurodegenerative diseases: Ethical and health communication challenges.Neurobiology of disease · 2020Review
Corrections and comments
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Authors and funding
17 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundIncreasing use of genetic testing raises questions about disclosing secondary findings, including pleiotropic information.
objectiveTo determine the safety and behavioral effect of disclosing modest associations between apolipoprotein E (APOE) genotype and coronary artery disease (CAD) risk during APOE-based genetic risk assessments for Alzheimer disease (AD).
designRandomized, multicenter equivalence clinical trial. (ClinicalTrials.gov: NCT00462917).
setting4 teaching hospitals.
participants257 asymptomatic adults were enrolled, 69% of whom had 1 AD-affected first-degree relative.
interventionDisclosure of genetic risk information about AD and CAD (AD+CAD) or AD only (AD-only). MEASUREMENTS: Primary outcomes were Beck Anxiety Inventory (BAI) and Center for Epidemiologic Studies Depression Scale (CES-D) scores at 12 months. Secondary outcomes were all measures at 6 weeks and 6 months and test-related distress and health behavior changes at 12 months.
resultsAt 12 months, mean BAI scores were 3.5 in both the AD-only and AD+CAD groups (difference, 0.0 [95% CI, -1.0 to 1.0]), and mean CES-D scores were 6.4 and 7.1 in the AD-only and AD+CAD groups, respectively (difference, 0.7 [CI, -1.0 to 2.4]). Both confidence bounds fell within the equivalence margin of ±5 points. Among carriers of the APOE ε4 allele, distress was lower in the AD+CAD groups (difference, -4.8 [CI, -8.6 to -1.0]) (P = 0.031 for the interaction between group and APOE genotype). Participants in the AD+CAD groups also reported more health behavior changes, regardless of APOE genotype. LIMITATIONS: Outcomes were self-reported by volunteers without severe anxiety, severe depression, or cognitive problems. Analyses omitted 33 randomly assigned participants.
conclusionDisclosure of pleiotropic information did not increase anxiety or depression and may have decreased distress among persons at increased risk for 2 conditions. Providing risk modification information about CAD improved health behaviors. Findings highlight the potential benefits of disclosure of secondary genetic findings when options exist for decreasing risk. PRIMARY FUNDING SOURCE: National Human Genome Research Institute.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.