Evidence map›Paper›PMID 38951633›Full record

ArticleScientific reports2024

Analysis of eligibility criteria in Alzheimer's and related dementias clinical trials.

Alexandra K Mitchell, Rebecca Ehrenkranz, Sanne Franzen, Sae H Han, Mujaahida Shakur, Melissa McGowan, Holly A Massett

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

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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

7 authors.

Alexandra K Mitchell *Kelly Government, Kelly Services, Inc., Rockville, MD, 20852, USA.
Rebecca Ehrenkranz *Kelly Government, Kelly Services, Inc., Rockville, MD, 20852, USA.
Sanne FranzenDepartment of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Sae H HanKelly Government, Kelly Services, Inc., Rockville, MD, 20852, USA.
Mujaahida ShakurDivision of Extramural Activities, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Ave., Ste 2S-603, Bethesda, MD, 20814, USA.
Melissa McGowanDivision of Extramural Activities, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Ave., Ste 2S-603, Bethesda, MD, 20814, USA.
Holly A MassettDivision of Extramural Activities, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Ave., Ste 2S-603, Bethesda, MD, 20814, USA. massetth@mail.nih.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Overly restrictive clinical trial eligibility criteria can reduce generalizability, slow enrollment, and disproportionately exclude historically underrepresented populations. The eligibility criteria for 196 Alzheimer's Disease and Related Dementias (AD/ADRD) trials funded by the National Institute on Aging were analyzed to identify common criteria and their potential to disproportionately exclude participants by race/ethnicity. The trials were categorized by type (48 Phase I/II pharmacological, 7 Phase III/IV pharmacological, 128 non-pharmacological, 7 diagnostic, and 6 neuropsychiatric) and target population (51 AD/ADRD, 58 Mild Cognitive Impairment, 25 at-risk, and 62 cognitively normal). Eligibility criteria were coded into the following categories: Medical, Neurologic, Psychiatric, and Procedural. A literature search was conducted to describe the prevalence of disparities for eligibility criteria for African Americans/Black (AA/B), Hispanic/Latino (H/L), American Indian/Alaska Native (AI/AN) and Native Hawaiian/Pacific Islander (NH/PI) populations. The trials had a median of 15 criteria. The most frequent criterion were age cutoffs (87% of trials), specified neurologic (65%), and psychiatric disorders (61%). Underrepresented groups could be disproportionately excluded by 16 eligibility categories; 42% of trials specified English-speakers only in their criteria. Most trials (82%) contain poorly operationalized criteria (i.e., criteria not well defined that can have multiple interpretations/means of implementation) and criteria that may reduce racial/ethnic enrollment diversity.

Indexed as

Alzheimer DiseaseClinical Trials as TopicPatient SelectionAmerican Indian or Alaska NativeBlack or African AmericanCognitive DysfunctionDementiaEligibility DeterminationEthnicityHispanic or LatinoHumansNational Institute on Aging (U.S.)Native Hawaiian or Pacific IslanderUnited StatesAlzheimer diseaseClinical trialsDementiaDiversityEligibility criteriaEquityHealth status disparitiesInclusionPatient selectionRecruitment

Identifiers

PMID38951633
PMCPMC11217383

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Registered trials

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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.