Evidence map›Paper›PMID 32999917›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2020

Enriching the design of Alzheimer's disease clinical trials: Application of the polygenic hazard score and composite outcome measures.

Sarah J Banks, Yuqi Qiu, Chun Chieh Fan, Anders M Dale, Jingjing Zou, Brianna Askew, Howard H Feldman, Alzheimer's Disease Neuroimaging Initiative

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 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

8 authors.

Sarah J BanksUniversity of California San Diego San Diego California USA.
Yuqi QiuUniversity of California San Diego San Diego California USA.
Chun Chieh FanUniversity of California San Diego San Diego California USA.
Anders M DaleUniversity of California San Diego San Diego California USA.
Jingjing ZouUniversity of California San Diego San Diego California USA.
Brianna AskewUniversity of California San Diego San Diego California USA.
Howard H FeldmanUniversity of California San Diego San Diego California USA.
Alzheimer's Disease Neuroimaging Initiative

Funding

Alzheimer's Disease Neuroimaging Initiative - SupplementU01AG024904 · NIA · NORTHERN CALIFORNIA INSTITUTE RES &EDUC · PI WEINER, MICHAEL W · 2004 to 2015
$121.0M
UCSD Shiley-Marcos Alzheimer's Disease Research Center P30P30AG062429 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Steven Dyal Edland · 2019 to 2026
$34.9M
Sex-specific cognitive expression and risk in preclinical Alzheimer's diseaseR01AG066088 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BANKS, SARAH · 2019 to 2023
$3.9M
NIA NIH HHS P30 AG062429NIA NIH HHS R01 AG066088NIA NIH HHS U01 AG024904
6 · The paper itself

Abstract

introductionSelecting individuals at high risk of Alzheimer's disease (AD) dementia and using the most sensitive outcome measures are important aspects of trial design.

methodsWe divided participants from Alzheimer's Disease Neuroimaging Initiative at the 50th percentile of the predicted absolute risk of the polygenic hazard score (PHS). Outcome measures were the Alzheimer's Disease Assessment Schedule-Cognitive Subscale (ADAS-Cog), ADNI-Mem, Clinical Dementia Rating-Sum of Boxes (CDR SB), and Cognitive Function Composite 2 (CFC2). In addition to modeling, we use a power analysis compare numbers needed with each technique.

resultsData from 188 cognitively normal and 319 mild cognitively impaired (MCI) participants were analyzed. Using the ADAS-Cog to estimate sample sizes, without stratification over 24 months, would require 930 participants with MCI, while using the CFC2 and restricting participants to those in the upper 50th percentile would require only 284 participants. DISCUSSION: Combining stratification by PHS and selection of a sensitive combined outcome measure in a cohort of patients with MCI can allow trial design that is more efficient, potentially less burdensome on participants, and more cost effective.

Indexed as

clinical trial designcognitionmild cognitive impairmentoutcomespolygenic hazard score

Identifiers

PMID32999917
PMCPMC7507583

What OpenQuestion holds

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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.