eprintid: 10073276
rev_number: 16
eprint_status: archive
userid: 608
dir: disk0/10/07/32/76
datestamp: 2019-05-10 14:30:58
lastmod: 2021-11-23 23:29:51
status_changed: 2019-05-10 14:30:58
type: article
metadata_visibility: show
creators_name: Wolz, R
creators_name: Schwarz, AJ
creators_name: Gray, KR
creators_name: Yu, P
creators_name: Hill, DLG
creators_name: Alzheimer's Disease Neuroimaging Initiative, 
title: Enrichment of clinical trials in MCI due to AD using markers of amyloid and neurodegeneration
ispublished: pub
divisions: UCL
divisions: B04
divisions: C05
divisions: F42
keywords: Aged, Alzheimer Disease, Amyloid beta-Peptides, Biomarkers, Brain, Clinical Trials as Topic, Cognitive Dysfunction, Cohort Studies, Female, Humans, Male, Mental Status Schedule, Nerve Degeneration, Positron-Emission Tomography
note: This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions.
abstract: OBJECTIVE: To investigate the effect of enriching mild cognitive impairment (MCI) clinical trials using combined markers of amyloid pathology and neurodegeneration. METHODS: We evaluate an implementation of the recent National Institute for Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for MCI due to Alzheimer disease (AD) as inclusion criteria in clinical trials and assess the effect of enrichment with amyloid (A+), neurodegeneration (N+), and their combination (A+N+) on the rate of clinical progression, required sample sizes, and estimates of trial time and cost. RESULTS: Enrichment based on an individual marker (A+ or N+) substantially improves all assessed trial characteristics. Combined enrichment (A+N+) further improves these results with a reduction in required sample sizes by 45% to 60%, depending on the endpoint. CONCLUSIONS: Operationalizing the NIA-AA diagnostic criteria for clinical trial screening has the potential to substantially improve the statistical power of trials in MCI due to AD by identifying a more rapidly progressing patient population.
date: 2016-09-20
date_type: published
official_url: https://doi.org/10.1212/WNL.0000000000003126
full_text_type: pub
pmcid: PMC5035986
language: eng
article_type_text: Journal Article
verified: verified_manual
elements_id: 1614043
doi: 10.1212/WNL.0000000000003126
pii: WNL.0000000000003126
lyricists_name: Hill, Derek
lyricists_id: DHILL80
actors_name: Hill, Derek
actors_id: DHILL80
actors_role: owner
full_text_status: restricted
publication: Neurology
volume: 87
number: 12
pagerange: 1235-1241
event_location: United States
issn: 1526-632X
citation:        Wolz, R;    Schwarz, AJ;    Gray, KR;    Yu, P;    Hill, DLG;    Alzheimer's Disease Neuroimaging Initiative;      (2016)    Enrichment of clinical trials in MCI due to AD using markers of amyloid and neurodegeneration.                   Neurology , 87  (12)   pp. 1235-1241.    10.1212/WNL.0000000000003126 <https://doi.org/10.1212/WNL.0000000000003126>.      
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10073276/1/1235.full.pdf