Evidence map›Paper›PMID 33933666›Full record

ArticleContemporary clinical trials2021

Development of novel measures for Alzheimer's disease prevention trials (NoMAD).

Sophie A Bell, Hannah R Cohen, Seonjoo Lee, Hyun Kim, Adam Ciarleglio, Howard Andrews, Andres M Rivera, Kay Igwe, Adam M Brickman, D P Devanand and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03900273 (Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 28% 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.

NCT03900273 nasuspendednot on this map

Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials

TypeinterventionalSponsorNew York State Psychiatric InstituteRan2019 to 2026Enrolled400ConditionsHealthy ParticipantsArmsNo Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS), Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. The Current Landscape of Prevention Trials in Dementia.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
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

13 authors at 7 institutions in 1 country.

Sophie A BellDivision of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA.
Hannah R CohenDivision of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA.
Seonjoo LeeDepartment of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA; Division of Mental Health Data Science, New York State Psychiatric Institute, New York, NY, USA.
Hyun KimDivision of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.
Adam CiarleglioDepartment of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
Howard AndrewsDepartment of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
Andres M RiveraDepartment of Neurology, Taub Institute for Research in Alzheimer's Disease and the Aging Brain, and Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
Kay IgweDepartment of Neurology, Taub Institute for Research in Alzheimer's Disease and the Aging Brain, and Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
Adam M BrickmanDepartment of Neurology, Taub Institute for Research in Alzheimer's Disease and the Aging Brain, and Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
D P DevanandDivision of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.
Philip D HarveyUniversity of Miami Miller School of Medicine, Miami VA Medical Center, Miami, FL, USA.
Lon S SchneiderUniversity of Southern California Keck School of Medicine, Los Angeles, CA, USA.
Terry E GoldbergDivision of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: teg2117@cumc.columbia.edu.
Columbia University · USColumbia University Irving Medical Center · USNew York Psychoanalytic Society and Institute · USNew York State Psychiatric InstituteMilken Institute · USUniversity of Miami · USUniversity of Southern California · US

Funding

USCADRC Diversity Supplement PachicanoP30AG066530 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HELENA Chang CHUI, ARTHUR W TOGA · 2020 to 2026
$27.8M
Novel Cognitive and Functional Measures for Alzheimer's Disease Prevention Trials: Sensitivity to BiomarkersR01AG051346 · NIA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI GOLDBERG, TERRY, HARVEY, PHILIP D. · 2018 to 2022
$9.8M
Research Training in Late-Life NeuroPsychiatric DisordersT32MH020004 · NIMH · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Patrick J Brown · 1998 to 2026
$6.1M
NIA NIH HHS P30 AG066530NIA NIH HHS R01 AG051346NIMH NIH HHS T32 MH020004
6 · The paper itself

Abstract

introductionAssessment of cognition and everyday function is essential in clinical trials for Alzheimer's disease (AD). Two novel measures of cognition (No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS)) were designed to have robust psychometric properties and reduced practice and ceiling effects. This study aims to evaluate if the NPE and CFAS demonstrate stronger psychometric properties and reduced practice effects compared with established measures, including the Preclinical Alzheimer Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Functional Activities Questionnaire (FAQ).

methodsThis parallel group, four-site study will randomize 320 cognitively intact adults aged 60 to 85 years to novel or well-established measures of cognition and function. All participants will receive assessments at baseline (week 0), 3-months, and 12-months, as well as a brain MRI scan and Apolipoprotein E genetic test at study entry. Analyses will determine psychometric properties of the NPE and CFAS, compare the sensitivity of measures to AD risk markers, and identify cognitive domains within the NPE. DISCUSSION: Practice effects have been a major limitation of Alzheimer's disease clinical trials that typically assess cognitive changes over serial assessments. Detection of functional impairment in cognitively normal individuals with biomarkers for Alzheimer's disease requires instruments sensitive to very subtle functional changes. This study is intended to support the validation of two new composite measures, the NPE battery and the CFAS, which may advance clinical testing of interventions for individuals across the spectrum of early stage Alzheimer's disease.

trial registrationNCT03900273.

Indexed as

Alzheimer DiseaseCognitive DysfunctionCognitionHumansNeuroimagingNeuropsychological TestsPsychometricsRandomized Controlled Trials as TopicAlzheimer's diseaseCognitionComputerized assessmentPractice effectsPreclinical Alzheimer's disease

Identifiers

PMID33933666
PMCPMC10001317
OpenAlexW3159033980

What OpenQuestion holds

Textmetadata
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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.