Evidence map›Paper›PMID 39578926›Full record

ArticleTrials2024

Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial.

Noll L Campbell, Richard J Holden, Sujuan Gao, Frederick W Unverzagt, Kathleen A Lane, Allie Carter, Addison B Harrington, Sneha Manoharan, Neha Manoharan, Danielle L Rosenthal and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04270474 (Reducing Risk of Dementia Through Deprescribing), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04270474 nacompletednot on this map

Reducing Risk of Dementia Through Deprescribing (R2D2)

TypeinterventionalSponsorIndiana UniversityRan2020 to 2026Enrolled344ConditionsDementia, Alzheimer Disease, Late OnsetArmsDeprescribing of target anticholinergics, Usual Care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Noll L CampbellDepartment of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA. campbenl@purdue.edu.ORCID http://orcid.org/0000-0002-8933-9339
Richard J HoldenCenter for Health Innovation and Implementation Science, Indiana University, Indianapolis, IN, USA.
Sujuan GaoDepartment of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA.
Frederick W UnverzagtDepartment of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
Kathleen A LaneDepartment of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA.
Allie CarterDepartment of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA.
Addison B HarringtonIndiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.
Sneha ManoharanIndiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.
Neha ManoharanIndiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.
Danielle L RosenthalIndiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.
Christopher PittsDepartment of Pharmacy, Indiana University Health, Indianapolis, IN, USA.
Kathryn PelkeyDepartment of Pharmacy, Community Health Network, Indianapolis, IN, USA.
Emily PapineauDepartment of Pharmacy, Community Health Network, Indianapolis, IN, USA.
David M LauckDepartment of Medicine, Community Health Network, Indianapolis, IN, USA.
Noha KeshkDepartment of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA.
Khalid AlamerPharmacy Practice Department, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Hussein KhalilDepartment of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA.
Malaz A BoustaniIndiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.

Funding

Reducing Risk of Dementia through De-prescribing (R2D2)R01AG061452 · NIA · PURDUE UNIVERSITY · PI CAMPBELL, NOLL L. · 2019 to 2023
$3.3M
NIA NIH HHS R01 AG061452NIA NIH HHS R01AG061452
6 · The paper itself

Abstract

backgroundOlder adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions and have been repeatedly associated with poor cognitive outcomes, including delirium and dementia, in epidemiologic studies. However, no study has definitively evaluated the causal relationship between anticholinergics and cognition in a randomized controlled trial design. Utilizing our prior experience in deprescribing anticholinergic medications in various clinical environments, we designed an outpatient deprescribing intervention to prospectively test the potential causal relationship between anticholinergics and cognition in primary care older adults.

methodsThis cluster randomized clinical trial will be conducted to evaluate the impact of an anticholinergic deprescribing intervention compared to usual care on outcomes of cognition and safety in primary care older adults. Participants will include those aged 65 years and over, receiving primary care in the greater Indianapolis area, using a strong anticholinergic within the last 2 weeks or with evidence of high-risk exposure in the past year. Those excluded will have a diagnosis of Alzheimer's disease or related dementia, or serious mental illness. The trial plans to enroll 344 participants who will be cluster-randomized at the level of primary care physician to avoid contamination. Participants will complete outcome assessments every 6 months up to 2 years by blinded outcome assessors. The primary outcome of the study is a composite measure of cognition that includes domains assessing executive cognitive function, language, and memory. Secondary outcomes include patient-reported measures of pain intensity, depression, anxiety, sleep disturbance, and health-related quality of life. DISCUSSION: The R2D2 trial will be the largest and longest prospective randomized trial testing the impact of an anticholinergic-specific deprescribing intervention on cognition in primary care older adults. Results could influence deprescribing methodology and provide new insight on the relationship between anticholinergics and cognition.

trial registrationClinicalTrials.gov NCT04270474. Registered on February 17, 2020.

Indexed as

Cholinergic AntagonistsCognitionDementiaDeprescriptionsRandomized Controlled Trials as TopicAgedCognitive DysfunctionFemaleHumansMalePrimary Health CareProspective StudiesQuality of LifeRisk FactorsTreatment OutcomeCholinergic AntagonistsAnticholinergicsCognitionDementiaDeprescribing

Identifiers

PMID39578926
PMCPMC11583418

What OpenQuestion holds

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LicenceCC BY
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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.