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.
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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.
| Type: | Article |
|---|---|
| Title: | Enrichment of clinical trials in MCI due to AD using markers of amyloid and neurodegeneration |
| Location: | United States |
| DOI: | 10.1212/WNL.0000000000003126 |
| Publisher version: | https://doi.org/10.1212/WNL.0000000000003126 |
| Language: | English |
| Additional information: | This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions. |
| 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 |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Med Phys and Biomedical Eng |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10073276 |
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