Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2015
A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.
Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
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
31 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Systematic Review of Randomized Controlled Trials to Assess Outcomes of Genetic Counseling.Journal of genetic counseling · 2017Pooled it
- Psychological, behavioral and social effects of disclosing Alzheimer's disease biomarkers to research participants: a systematic review.Alzheimer's research & therapy · 2016Pooled 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
- 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
- Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial.Annals of internal medicine · 2016Trial
- Article
- Now is the time: the need to update guidance to expand access toFrontiers in dementia · 2026Article
- Impact of learning APOE genotype on cognitively unimpaired adults: a pre-screening cohort study of the Alzheimer's Prevention Initiative Generation Study 1.The lancet. Healthy longevity · 2025Article
- Communicating the risk of dementia: a scoping review.BMJ neurology open · 2025Article
- Ethical disclosure of biomarkers for Alzheimer risk in Latin American participants.Frontiers in dementia · 2025Article
- Interest in genetic susceptibility testing and disclosure of AD dementia risk in cognitively normal adults: a survey study.Alzheimer's research & therapy · 2024Article
- Lecanemab: Appropriate Use Recommendations.The journal of prevention of Alzheimer's disease · 2023Article
- Disclosure of Genetic Risk Factors for Alzheimer's Disease to Cognitively Healthy Individuals-From Current Practice towards a Personalised Medicine Scenario.Biomedicines · 2022Review
- Communicating 5-Year Risk of Alzheimer's Disease Dementia: Development and Evaluation of Materials that Incorporate Multiple Genetic and Biomarker Research Results.Journal of Alzheimer's disease : JAD · 2021Article
- Genetic testing for neurodegenerative diseases: Ethical and health communication challenges.Neurobiology of disease · 2020Review
- Disclosing genetic risk for Alzheimer's dementia to individuals with mild cognitive impairment.Alzheimer's & dementia (New York, N. Y.) · 2020Article
- Rural stakeholder perceptions about cognitive screening.Aging & mental health · 2019Article
- Assessing the Psychological Impact of Genetic Susceptibility Testing.The Hastings Center report · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
introductionConventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD.
methodsA randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure.
resultsThree hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans.
conclusionsThese data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information.
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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.