Evidence map›Paper›PMID 27520290›Full record

ReviewAlzheimer's research & therapy2016

Older patients are still under-represented in clinical trials of Alzheimer's disease.

Rita Banzi, Paolo Camaioni, Mauro Tettamanti, Vittorio Bertele', Ugo Lucca

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Alzheimer's research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 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

46 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  19. Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
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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

5 authors.

Rita BanziLaboratorio Politiche Regolatorie del Farmaco, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milan, 20156, Italy. rita.banzi@marionegri.it.
Paolo CamaioniLaboratorio di Neuropsichiatria Geriatrica, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milan, 20156, Italy.
Mauro TettamantiLaboratorio di Neuropsichiatria Geriatrica, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milan, 20156, Italy.
Vittorio Bertele'Laboratorio Politiche Regolatorie del Farmaco, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milan, 20156, Italy.
Ugo LuccaLaboratorio di Neuropsichiatria Geriatrica, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milan, 20156, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe age gap between participants in trials and patients who could benefit from the drugs studied has been widely documented across different clinical areas. Patients with dementia included in clinical research are systematically younger than those in the general population. We examined the age gap between participants in recent clinical trials testing interventions for Alzheimer's disease and epidemiological data.

methodsWe systematically searched literature databases (MedLine, EMBASE, the Cochrane Library) and ClinicalTrials.gov from 2000 to July 2015 to retrieve clinical trials testing pharmacologic treatments for Alzheimer's disease, other than cholinesterase inhibitors and memantine. We included ongoing and completed phase II/III randomized clinical trials, irrespective of their publication status. From each study reporting the participants' ages, we extracted size of sample, mean age, and standard deviation, and estimated the proportions of participants in different age classes. The number of patients with Alzheimer's disease by age class in the USA population was used for comparison.

resultsWe included 165 clinical trials testing almost 100 different compounds, which enrolled or planned to enroll about 74,300 participants. Seventy-nine of these trials, accounting for about 26,800 participants, reported the age of the participants. The weighted mean age was 73.6 years (standard deviation, 8.2). People younger than 80 years were highly represented in clinical trials (78 %), despite the fact that those aged 80 and older form the majority (72 %) of patients with Alzheimer's disease. Only 8 % of clinical trial participants were 85 years or older.

conclusionsPatients enrolled in clinical trials on Alzheimer's disease are far from being representative of actual distribution of the patients in the general population. Clinical research should not be designed and conducted overlooking the fact that the majority of individuals with Alzheimer's disease are likely to be 80 or older.

Indexed as

Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicRandomized Controlled Trials as TopicAgedAged, 80 and overAge FactorsAlzheimer DiseaseHumansMiddle AgedAgeAlzheimer’s diseaseClinical trialsDisease-modifying drugsExternal validityInclusion criteriaTrial participants

Identifiers

PMID27520290
PMCPMC4982205

What OpenQuestion holds

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LicenceCC BY
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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.