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Introduction:

One challenge with clinical trials in Alzheimer’s Disease (AD) prevention is the timely identification of individuals at near-term risk of cognitive symptom onset, mitigating the prohibitive costs associated with trial size and duration.  A biomarker algorithm, consisting of genotypes at the apolipoprotein E (APOE) and translocase of outer mitochondrial membrane 40 homolog (TOMM40) rs10524523 (‘523) loci and current age, was developed to enrich the TOMMORROW delay of AD-onset clinical study (NCT01931566). ‘523 is a homopolymer of 14–50 thymine (T) residues.  For the biomarker algorithm, the ‘523 alleles were categorized by poly-T length as short (S; < 20 nucleotides), long (L; ≤ 20 to ≤ 29 nucleotides) or very long (VL; > 29 nucleotides). The biomarker algorithm is described in Crenshaw et al., and the TOMMORROW study design is described in Burns et al. and Roses et al. The TOMMORROW study was terminated at futility analysis and study findings are the subject of a manuscript in preparation. Statistical analysis of biomarker algorithm performance compared with biofluid and imaging biomarkers for the prediction of mild cognitive impairment (MCI) due to AD in a 5-year time frame is described in Lutz et al.

Authors: MW Lutz, DK Burns, R Alexander, M Culp,D Yarnall, S Haneline, C Chiang,2 E Lai, C Metz, S Sundseth, T Guennel, S Marshall,BF Andruss, GJ Latham, B Hall, SN Statt, T Swanson, E Ratti, and AM Saunders

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