Evidence map›Paper›PMID 23782591›Full record

Trial reportTrials2013

Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial.

Noll L Campbell, Paul Dexter, Anthony J Perkins, Sujuan Gao, Lang Li, Todd C Skaar, Amie Frame, Hugh C Hendrie, Chris M Callahan, Malaz A Boustani

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01362686 (Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT01362686 naterminatednot on this map

Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs

TypeinterventionalSponsorIndiana UniversityRan2011 to 2015Enrolled200ConditionsDementia, Alzheimer's DiseaseArmsDonepezil, Galantamine, Rivastigmine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  6. Review
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

10 authors.

Noll L CampbellDepartment of Pharmacy Practice, Purdue University School of Pharmacy, 410 West 10th Street, West Lafayette, IN, USA. campbenl@iupui.edu
Paul Dexter
Anthony J Perkins
Sujuan Gao
Lang Li
Todd C Skaar
Amie Frame
Hugh C Hendrie
Chris M Callahan
Malaz A Boustani

Funding

Indiana PROSPECTR01HS019818 · AHRQ · INDIANA UNIVERSITY INDIANAPOLIS · PI DEXTER, PAUL · 2010 to 2010
$8.4M
Regulation of drug metabolizing enzymes by miRNAsR01GM088076 · NIGMS · INDIANA UNIVERSITY INDIANAPOLIS · PI SKAAR, TODD C. · 2009 to 2017
$3.8M
AHRQ HHS R01HS019818-01NIGMS NIH HHS R01 GM088076
6 · The paper itself

Abstract

backgroundThe class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer's disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence. METHODS/

designWe designed a pragmatic randomized clinical trial to evaluate the adherence to ChEIs among older adults with AD. Participants include AD patients receiving care within memory care practices in the greater Indianapolis area. Participants will be followed at 6-week intervals up to 18 weeks to measure the primary outcome of ChEI discontinuation and adherence rates and secondary outcomes of behavioral and psychological symptoms of dementia. The primary outcome will be assessed through two methods, a telephone interview of an informal caregiver and electronic medical record data captured from each healthcare system through a regional health information exchange. The secondary outcome will be measured by the Healthy Aging Brain Care Monitor and the Neuropsychiatric Inventory. In addition, the trial will conduct an exploratory evaluation of the pharmacogenomic signatures for the efficacy and the adverse effect responses to ChEIs. We hypothesized that patient-specific factors, including pharmacogenomics and pharmacokinetic characteristics, may influence the study outcomes. DISCUSSION: This pragmatic trial will engage a diverse population from multiple memory care practices to evaluate the adherence to and tolerability of ChEIs in a real world setting. Engaging participants from multiple healthcare systems connected through a health information exchange will capture valuable clinical and non-clinical influences on the patterns of utilization and tolerability of a class of medications with a high rate of discontinuation.

trial registrationClinicaltrials.gov: NCT01362686.

Indexed as

Medication AdherenceResearch DesignAgedAlzheimer DiseaseBrainCholinesterase InhibitorsClinical ProtocolsComorbidityDrug InteractionsFemaleHumansIndianaMaleMemoryMiddle AgedNeuropsychological TestsCholinesterase InhibitorsNootropic Agents

Identifiers

PMID23782591
PMCPMC3764973

What OpenQuestion holds

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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.