Evidence map›Paper›PMID 41910458›Full record

ArticleJournal of Alzheimer's disease : JAD2026

Alternative clinical trial designs to find a clinically important effect size of blood pressure-lowering on cognitive impairment and dementia.

Deborah A Levine, Rodney A Hayward, Jeremy B Sussman, Rachael T Whitney, Andrzej T Gałecki, Emily M Briceño, Alden L Gross, Bruno J Giordani, Mitchell S V Elkind, Darrell J Gaskin and 4 more

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In one paragraph

Article in Journal of Alzheimer's disease : JAD, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Deborah A LevineDepartment of Internal Medicine and Cognitive Health Services Research Program, University of Michigan (U-M), Ann Arbor, MI, USA.ORCID 0000-0002-6864-8001
Rodney A HaywardInstitute for Healthcare Policy and Innovation, U-M, Ann Arbor, MI, USA.
Jeremy B SussmanInstitute for Healthcare Policy and Innovation, U-M, Ann Arbor, MI, USA.
Rachael T WhitneyDepartment of Internal Medicine and Cognitive Health Services Research Program, University of Michigan (U-M), Ann Arbor, MI, USA.
Andrzej T GałeckiDepartment of Biostatistics, U-M, Ann Arbor, MI, USA.
Emily M BriceñoDepartment of Internal Medicine and Cognitive Health Services Research Program, University of Michigan (U-M), Ann Arbor, MI, USA.
Alden L GrossDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Bruno J GiordaniDepartment of Psychiatry & Michigan Alzheimer's Disease Center, U-M, Ann Arbor, MI, USA.
Mitchell S V ElkindDepartment of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.ORCID 0000-0003-2562-1156
Darrell J GaskinDepartment of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Rebecca F GottesmanStroke Branch, National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
Stephen SidneyDivision of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
Kristine YaffeDepartments of Psychiatry, Neurology and Epidemiology, University of California, San Francisco, San Francisco, CA, USA.
James F BurkeDepartment of Neurology, Ohio State College of Medicine, Columbus, OH, USA.

Funding

ARIC Neurocognitive Study (ARIC-NCS) Renewal 2023-2028U01HL096812 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI JOSEF CORESH, THOMAS H MOSLEY · 2010 to 2026
$65.7M
FRAMINGHAM HEART STUDY - YEAR 5 EXAM75N92019D00031 · NHLBI · BOSTON UNIVERSITY MEDICAL CAMPUS · 2019 to 2024
$29.8M
Research Education CoreP30AG024824 · NIA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Lona Mody, RAYMOND L YUNG · 2004 to 2026
$29.2M
Research Education ComponentP30AG072931 · NIA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Henry L Paulson · 2021 to 2026
$26.5M
Regional Pilot And Feasibility Study Grants ProgramP30DK020572 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI DAVID P OLSON · 2013 to 2026
$24.3M
STROKE INCIDENCE AND RISK FACTORS IN A TRI-ETHNIC REGIONR01NS029993 · NINDS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI ELKIND, MITCHELL S, SACCO, RALPH L. · 1993 to 2019
$19.2M
THE ATHEROSCLEROSIS RISK IN COMMUNITIES (ARIC) STUDY - COORDINATING CENTER - TASK AREA B.2 AND B.375N92022D00001 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI COUPER, DAVID · 2022 to 2025
$13.7M
ARIC Neurocognitive Study (ARIC-NCS) Renewal 2 of 5U01HL096917 · NHLBI · UNIVERSITY OF MISSISSIPPI MED CTR · PI MOSLEY, THOMAS H · 2010 to 2018
$11.9M
Exceptional Survival: Trajectories to Functional Aging (CHS All Stars)R01AG023629 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI NEWMAN, ANNE B. · 2004 to 2016
$9.5M
CARDIOVASCULAR HEALTH STUDY (CHS) - TASK AREA C, STUDY CLOSEOUT75N92021D00006 · NHLBI · UNIVERSITY OF WASHINGTON · PI PSATY, BRUCE · 2021 to 2024
$8.4M
ARIC Neurocognitive Study (ARIC-NCS) Renewal UNC 4 of 5U01HL096899 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI COUPER, DAVID J · 2010 to 2018
$7.5M
ARIC Neurocognitive Study (ARIC-NCS)U01HL096902 · NHLBI · UNIVERSITY OF MINNESOTA · PI LUTSEY, PAMELA L. · 2010 to 2018
$7.4M
NHLBI NIH HHS 75N92019D00031NHLBI NIH HHS 75N92021D00006NHLBI NIH HHS 75N92022D00001NHLBI NIH HHS 75N92022D00002NHLBI NIH HHS 75N92022D00003NHLBI NIH HHS 75N92022D00004NHLBI NIH HHS 75N92022D00005NHLBI NIH HHS 75N92023D00002NHLBI NIH HHS 75N92023D00003NHLBI NIH HHS 75N92023D00004NHLBI NIH HHS 75N92023D00005NHLBI NIH HHS 75N92023D00006NHLBI NIH HHS HHSN268200800007CNHLBI NIH HHS HHSN268201200036CNHLBI NIH HHS HHSN268201800001CNHLBI NIH HHS N01 HC055222NHLBI NIH HHS N01 HC085079NHLBI NIH HHS N01 HC085080NHLBI NIH HHS N01 HC085081NHLBI NIH HHS N01 HC085082NHLBI NIH HHS N01 HC085083NHLBI NIH HHS N01 HC085086NHLBI NIH HHS N01HC55222NHLBI NIH HHS N01HC85080NHLBI NIH HHS N01HC85081NHLBI NIH HHS N01HC85082NHLBI NIH HHS N01HC85083NHLBI NIH HHS N01HC85086NHLBI NIH HHS R01 HL172803NHLBI NIH HHS U01 HL080295NHLBI NIH HHS U01 HL096812NHLBI NIH HHS U01 HL096814NHLBI NIH HHS U01 HL096899NHLBI NIH HHS U01 HL096902NHLBI NIH HHS U01 HL096917NHLBI NIH HHS U01 HL130114NIA NIH HHS K01 AG050699NIA NIH HHS K23 AG080035NIA NIH HHS P30 AG024824NIA NIH HHS P30 AG072931NIA NIH HHS R01 AG023629NIA NIH HHS R01 AG068410NIA NIH HHS RF1 AG068410NIDDK NIH HHS P30 DK020572NINDS NIH HHS R01 NS029993NINDS NIH HHS R01 NS102715
6 · The paper itself

Abstract

BackgroundBlood pressure (BP) lowering might reduce the risk of cognitive impairment and dementia (CID), but more information is needed to design trials optimally.ObjectiveTo estimate trial sample sizes and durations for detecting BP-lowering effects on CID.MethodsWe estimated trial sample sizes and durations for finding an effect of a Systolic Blood PRessure INtervention Trial (SPRINT)-based BP-lowering strategy versus usual care on CID and global cognition using our MIchigan ChROnic Disease SIMulation Model (MICROSIM), which simulated adults with the US population's demographics and vascular risk factors and assumed BP-lowering's effect on CID and global cognition from our pooled cardiovascular cohort study.ResultsOver >139 million simulated trials across 78,000 parameters, the SPRINT-based BP-lowering strategy (versus usual care) resulted in a 2% CID relative risk reduction (RRR), much smaller than the CID RRR (15%) found in SPRINT Memory and Cognition IN Decreased Hypertension (MIND). Detecting a 2% CID RRR with >80% power would require 10-year trials with samples >50,000. Identifying the BP-lowering strategy's effect on mean global cognition would require trials of ≥10 years with >30,000 participants. However, trials of 5 years with 10,000 participants would have the power to detect the strategy's effect assuming a 15% CID RRR in SPRINT MIND.ConclusionsIn this microsimulation study, we found that trials would need to be large with long follow-ups to identify the causal effects of BP-lowering on CID and cognition. However, assuming the 15% CID RRR in SPRINT MIND, trials with more feasible sizes and durations could detect those effects.

Indexed as

Antihypertensive AgentsBlood PressureClinical Trials as TopicCognitive DysfunctionDementiaHypertensionResearch DesignAgedCohort StudiesComputer SimulationFemaleHumansMaleSample SizeAntihypertensive AgentsAlzheimer's diseaseblood pressurecognitiondementia

Identifiers

PMID41910458
PMCPMC13120728

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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.