Evidence map›Paper›PMID 29212555›Full record

ReviewAlzheimer's research & therapy2017

Study partners should be required in preclinical Alzheimer's disease trials.

Joshua D Grill, Jason Karlawish

Abstract readReview
In one paragraph

Review in Alzheimer's research & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–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

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Longitudinal Trajectories of the Cognitive Function Index in the A4 Study.The journal of prevention of Alzheimer's disease · 2024
    Trial
  3. Article
  4. Article
  5. Article
  6. Study partner characteristics moderate the prediction of cognitive decline in aging.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  7. Advancing Aging Research Through a Health Disparities Perspective.The journals of gerontology. Series A, Biological sciences and medical sciences · 2024
    Article
  8. Brain Health Registry Study Partner Portal: Novel infrastructure for digital, dyadic data collection.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  9. Views and Perceptions of Amyloid Imaging in a Preclinical Alzheimer's Disease Trial.The journal of prevention of Alzheimer's disease · 2024
    Article
  10. Article
  11. Article
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  16. Review
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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

2 authors.

Joshua D GrillDepartments of Psychiatry and Human Behavior and Neurobiology and Behavior, Institute for Memory Impairments and Neurological Disorders, 3204 Biological Sciences III, University of California, Irvine, CA, 92697, USA. jgrill@uci.edu.ORCID http://orcid.org/0000-0002-4215-7589
Jason KarlawishDepartments of Medicine, Medical Ethics and Health Policy, and Neurology, Penn Memory Center, University of Pennsylvania, Philadelphia, PA, USA.

Funding

UC Irvine Alzheimer's Disease Research Center Induced Pluripotent Stem Cell CoreP50AG016573 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI LAFERLA, FRANK M · 2000 to 2019
$37.0M
UPenn ADCC Biomarker CoreP30AG010124 · NIA · UNIVERSITY OF PENNSYLVANIA · PI DETRE, JOHN A · 1991 to 2020
$35.1M
The study partner requirement in preclinical Alzheimers disease trialsR21AG056931 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI GILLEN, DANIEL L, GRILL, JOSHUA · 2017 to 2018
$406k
National Institute on Aging AG056931NIA NIH HHS P30 AG010124NIA NIH HHS P50 AG016573
6 · The paper itself

Abstract

backgroundIn an effort to intervene earlier in Alzheimer's disease (AD), clinical trials are testing promising candidate therapies in preclinical disease. Preclinical AD trial participants are cognitively normal, functionally independent, and autonomous decision-makers. Yet, like AD dementia trials, preclinical trials require dual enrollment of a participant and a knowledgeable informant, or study partner. MAIN TEXT: The requirement of dyadic enrollment is a barrier to recruitment and may present unique ethical challenges. Despite these limitations, the requirement should continue. Study partners may be essential to ensure participant safety and wellbeing, including overcoming distress related to biomarker disclosure and minimizing risk for catastrophic reactions and suicide. The requirement may maximize participant retention and ensure data integrity, including that study partners are the source of data that will ultimately instruct whether a new treatment has a clinical benefit and meaningful impact on the population health burden associated with AD. Finally, study partners are needed to ensure the scientific and clinical value of trials.

conclusionsPreclinical AD will represent a new model of care, in which persons with no symptoms are informed of probable cognitive decline and eventual dementia. The rationale for early diagnosis in symptomatic AD is equally applicable in preclinical AD-to minimize risk, maximize quality of life, and ensure optimal planning and communication. Family members and other sources of support will likely be essential to the goals of this new model of care for preclinical AD patients and trials must instruct this clinical practice.

Indexed as

Alzheimer DiseaseClinical Trials as TopicCaregiversHumansInformed ConsentPatient ParticipationBiomarkerClinical trialInformantPreclinical Alzheimer’s diseaseStudy partner

Identifiers

PMID29212555
PMCPMC5719524

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.