Evidence map›Paper›PMID 31907024›Full record

ArticleTrials2020

Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial).

Danni Li, Michelle M Mielke, W Robert Bell, Cavan Reilly, Lin Zhang, Feng Vankee Lin, Fang Yu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03313895 (Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 31% 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.

NCT03313895 nacompletednot on this map

Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI

TypeinterventionalSponsorArizona State UniversityRan2018 to 2024Enrolled146ConditionsMild Cognitive ImpairmentArmsAerobic & Cognitive Training (ACT), Cycling Only, Cognitive Training Only, Stretching and Mental Stimulating Activities
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
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 at 3 institutions in 1 country.

Danni LiDepartment of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA. dannili@umn.edu.
Michelle M MielkeDepartment of Neurology and Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, 55902, USA.
W Robert BellDepartment of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA.
Cavan ReillyDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.
Lin ZhangDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.
Feng Vankee LinUniversity of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY 14642, USA.
Fang YuSchool of Nursing, University of Minnesota, 5-140 WDH, 308 Harvard St SE, Minneapolis, MN, 55455, USA. yuxxx244@umn.edu.
University of Minnesota · USMayo Clinic · USUniversity of Rochester Medical Center · US

Funding

Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
Blood Biomarkers as Surrogate Endpoints of Treatment Responses to Aerobic Exercise and/or Cognitive Training in Amnestic Mild Cognitive ImpairmentR01AG059654 · NIA · UNIVERSITY OF MINNESOTA · PI LI, DANNI · 2018 to 2022
$2.2M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR002494NCI NIH HHS P30 CA077598NIA NIH HHS R01 AG059654NIA NIH HHS R01AG059654-01
6 · The paper itself

Abstract

backgroundAlzheimer's disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia often use clinical endpoints that take years to manifest (e.g., cognition) or surrogate endpoints that are costly or invasive (e.g., magnetic resonance imaging [MRI]). Blood biomarkers represent a clinically applicable alternative surrogate endpoint for RCTs that would be both cost-effective and minimally invasive, but little is known about their value as surrogate endpoints for treatment responses in the prevention of AD dementia.

methodsThe objective of this study is to investigate blood neuropathological, neurodegenerative, and neurotrophic biomarkers as surrogate endpoints for treatment responses to three interventions in older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD): aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT). We chose these three sets of biomarkers for their unique mechanistic associations with AD pathology, neurodegeneration and neurogenesis. This study is built on the ACT Trial (1R01AG055469), a single-blinded, multi-site, 2 × 2 factorial phase II RCT that examines the synergistic effects of a 6-month ACT intervention on cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume) (n = 128). In this ACT Trial blood biomarkers study, we will enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18 months. The goals are to (1) determine the effect of interventions on blood biomarkers over 6 months, (2) evaluate blood biomarkers as surrogate endpoints for predicting cognitive responses to interventions over 18 months, and (3, exploratory) examine blood biomarkers as surrogate endpoints for predicting brain MRI biomarker responses to interventions over 18 months. DISCUSSION: This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training. Findings from this study will drive the further use of blood biomarkers in developing effective prevention and treatment strategies for AD dementia.

trial registrationClinicalTrials.gov, NCT03313895. Registered on 18 October 2017.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseBiomarkersCognitionCognitive DysfunctionDementiaDisease ProgressionExerciseExercise TherapyFemaleHumansMagnetic Resonance ImagingMaleNeuropsychological TestsRandomized Controlled Trials as TopicBiomarkersAerobic exerciseAlzheimer’s diseaseBlood biomarkersCognitive trainingNeurodegenerative biomarkersNeuropathological biomarkersNeurotrophic biomarkersSurrogate endpointsTreatment responses and amnestic mild cognitive impairment

Identifiers

PMID31907024
PMCPMC6943901
OpenAlexW3003057273

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.