Jeff D Williamson1, Nicholas M Pajewski2, Alexander P Auchus3, R Nick Bryan4, Gordon Chelune5, Alfred K Cheung6, Maryjo L Cleveland1, Laura H Coker7, Michael G Crowe8, William C Cushman9, Jeffrey A Cutler10, Christos Davatzikos4, Lisa Desiderio4, Guray Erus4, Larry J Fine11, Sarah A Gaussoin2, Darrin Harris2, Meng-Kang Hsieh4, Karen C Johnson12, Paul L Kimmel13, Manjula Kurella Tamura14, Lenore J Launer15, Alan J Lerner16, Cora E Lewis17, Jennifer Martindale-Adams12, Claudia S Moy18, Ilya M Nasrallah4, Linda O Nichols9, Suzanne Oparil19, Paula K Ogrocki16, Mahboob Rahman20, Stephen R Rapp21, David M Reboussin2, Michael V Rocco22, Bonnie C Sachs23, Kaycee M Sink1, Carolyn H Still24, Mark A Supiano25, Joni K Snyder10, Virginia G Wadley19, Jennifer Walker1, Daniel E Weiner26, Paul K Whelton27, Valerie M Wilson1, Nancy Woolard1, Jackson T Wright28, Clinton B Wright18. 1. Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina. 2. Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina. 3. Department of Neurology, University of Mississippi Medical Center, Jackson. 4. Department of Radiology, University of Pennsylvania, Philadelphia. 5. Department of Neurology, University of Utah School of Medicine, Salt Lake City. 6. Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City. 7. Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina. 8. Department of Psychology, University of Alabama at Birmingham. 9. Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, Tennessee. 10. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland. 11. Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland. 12. Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis. 13. Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Disorders, Bethesda, Maryland. 14. Division of Nephrology, Stanford University School of Medicine; Palo Alto, California. 15. Neuroepidemiology Section, Intramural Research Program, National Institute on Aging, Bethesda, Maryland. 16. Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, Ohio. 17. Department of Epidemiology, University of Alabama at Birmingham. 18. National Institute of Neurological Disorders and Stroke, Bethesda, Maryland. 19. Department of Medicine, University of Alabama at Birmingham. 20. Department of Medicine, Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University, Cleveland, Ohio. 21. Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina. 22. Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina. 23. Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina. 24. Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio. 25. Division of Geriatrics, University of Utah School of Medicine, Salt Lake City. 26. Division of Nephrology, Tufts Medical Center, Boston, Massachusetts. 27. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana. 28. Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio.
Abstract
Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.
RCT Entities:
Importance: There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia. Objective: To evaluate the effect of intensive blood pressure control on risk of dementia. Design, Setting, and Participants: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018. Interventions: Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia. Results: Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97). Conclusions and Relevance: Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.
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