Browsing by Author "Rosen, Allyson C."

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    Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial
    (Wolters Kluwer, 2015-12) Henderson, Victor W.; Ala, Tom; Sainani, Kristin L.; Bernstein, Allan L.; Stephenson, B. Sue; Rosen, Allyson C.; Farlow, Martin R.; Department of Neurology, IU School of Medicine
    OBJECTIVE: To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. METHODS: This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). RESULTS: Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. CONCLUSIONS: Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect.
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    The Advisory Group on Risk Evidence Education for Dementia: Multidisciplinary and Open to All
    (IOS Press, 2022) Rosen, Allyson C.; Arias, Jalayne J.; Ashford, J. Wesson; Blacker, Deborah; Chhatwal, Jasmeer P.; Chin, Nathan A.; Clark, Lindsay; Denny, Sharon S.; Goldman, Jill S.; Gleason, Carey E.; Grill, Joshua D.; Heidebrink, Judith L.; Henderson, Victor W.; Lavacot, James A.; Lingler, Jennifer H.; Menon, Malavika; Nosheny, Rachel L.; Oliveira, Fabricio F.; Parker, Monica W.; Rahman-Filipiak, Annalise; Revoori, Anwita; Rumbaugh, Malia C.; Sanchez, Danurys L.; Schindler, Suzanne E.; Schwarz, Christopher G.; Toy, Leslie; Tyrone, Jamie; Walter, Sarah; Wang, Li-san; Wijsman, Ellen M.; Zallen, Doris T.; Aggarwal, Neelum T.; Medical and Molecular Genetics, School of Medicine
    The brain changes of Alzheimer’s disease and other degenerative dementias begin long before cognitive dysfunction develops, and in people with subtle cognitive complaints, clinicians often struggle to predict who will develop dementia. The public increasingly sees benefits to accessing dementia risk evidence (DRE) such as biomarkers, predictive algorithms, and genetic information, particularly as this information moves from research to demonstrated usefulness in guiding diagnosis and clinical management. For example, the knowledge that one has high levels of amyloid in the brain may lead one to seek amyloid reducing medications, plan for disability, or engage in health promoting behaviors to fight cognitive decline. Researchers often hesitate to share DRE data, either because they are insufficiently validated or reliable for use in individuals, or there are concerns about assuring responsible use and ensuring adequate understanding of potential problems when one’s biomarker status is known. Concerns include warning people receiving DRE about situations in which they might be compelled to disclose their risk status potentially leading to discrimination or stigma. The Advisory Group on Risk Evidence Education for Dementia (AGREEDementia) welcomes all concerned with how best to share and use DRE. Supporting understanding in clinicians, stakeholders, and people with or at risk for dementia and clearly delineating risks, benefits, and gaps in knowledge is vital. This brief overview describes elements that made this group effective as a model for other health conditions where there is interest in unfettered collaboration to discuss diagnostic uncertainty and the appropriate use and communication of health-related risk information.