Evidence map›Paper›PMID 31720367›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2019

The TOMMORROW study: Design of an Alzheimer's disease delay-of-onset clinical trial.

Daniel K Burns, Carl Chiang, Kathleen A Welsh-Bohmer, Stephen K Brannan, Meredith Culp, Janet O'Neil, Grant Runyan, Patrick Harrigan, Brenda L Plassman, Michael Lutz and 8 more

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.3field-weighted citation impact, top 8% of its field
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

24 citing papers in PubMed, 41 citations in OpenAlex.

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  16. The Current Landscape of Prevention Trials in Dementia.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
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  19. The Neurovascular Unit Dysfunction in Alzheimer's Disease.International journal of molecular sciences · 2021
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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

18 authors at 4 institutions in 1 country.

Daniel K BurnsZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Carl ChiangZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Kathleen A Welsh-BohmerDepartment of Neurology, Bryan Alzheimer's Disease Research Center, Duke University School of Medicine, Durham, NC, USA.
Stephen K BrannanTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Meredith CulpTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Janet O'NeilTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Grant RunyanTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Patrick HarriganTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Brenda L PlassmanDepartment of Neurology, Bryan Alzheimer's Disease Research Center, Duke University School of Medicine, Durham, NC, USA.
Michael LutzDepartment of Neurology, Bryan Alzheimer's Disease Research Center, Duke University School of Medicine, Durham, NC, USA.
Eric LaiTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Stephen HanelineZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
David YarnallZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Deborah YarbroughTakeda Development Center Americas, Inc., Deerfield, IL, USA.
Craig MetzZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Sridevi PonduruTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Scott SundsethZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Ann M SaundersZinfandel Pharmaceuticals, Inc., Durham, NC, USA.
Cloud Pharmaceuticals (United States) · USDeerfield (United States) · USAlzheimer’s Disease Neuroimaging Initiative · USTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlzheimer's disease (AD) is a continuum with neuropathologies manifesting years before clinical symptoms; thus, AD research is attempting to identify more disease-modifying approaches to test treatments administered before full disease expression. Designing such trials in cognitively normal elderly individuals poses unique challenges.

methodsThe TOMMORROW study was a phase 3 double-blind, parallel-group study designed to support qualification of a novel genetic biomarker risk assignment algorithm (BRAA) and to assess efficacy and safety of low-dose pioglitazone to delay onset of mild cognitive impairment due to AD. Eligible participants were stratified based on the BRAA (using

resultsThe focus of this paper is on the design of the study; study results will be presented in a separate paper. DISCUSSION: The design of the TOMMORROW study addressed many key challenges to conducting a dual-objective phase 3 pivotal AD clinical trial in presymptomatic individuals. Experiences from planning and executing the TOMMORROW study may benefit future AD prevention/delay-of-onset trials.

Indexed as

Clinical trial designDelay of onsetGenetic risk for ADMild cognitive impairment due to ADTime to eventTrial population enrichment

Identifiers

PMID31720367
PMCPMC6838537
OpenAlexW2982482012

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.