Characterizing and validating 12-month reliable cognitive change in Early-Onset Alzheimer's Disease for use in clinical trials.
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Hammers Dustin B, Musema Jane, Eloyan Ani, Thangarajah Maryanne, Taurone Alexander, La Joie Renaud, Touroutoglou Alexandra, Vemuri Prashanthi, Kramer Joel, Aisen Paul, Dage Jeffrey L, Nudelman Kelly N, Kirby Kala, Atri Alireza, Clark David, Day Gregory S, Duara Ranjan, Graff-Radford Neill R, Grant Ian, Honig Lawrence S, Johnson Erik C B, Jones David T, Masdeu Joseph C, Mendez Mario F, Womack Kyle, Musiek Erik, Onyike Chiadi U, Riddle Meghan, Rogalski Emily, Salloway Steven, Sha Sharon J, Turner Raymond Scott, Wingo Thomas S, Wolk David A, Carrillo Maria C, Rabinovici Gil D, Dickerson Bradford C, Apostolova Liana G, LEADS Consortium
Аннотация
OBJECTIVES: The current study sought to characterize and validate 12-month reliable change from the Longitudinal Early-Onset Alzheimer's Disease Study (LEADS) neuropsychological battery.
DESIGN: Standardized regression-based (SRB) prediction equations were developed from age-matched cognitively intact participants within LEADS, and applied to clinically impaired participants from LEADS.
SETTING: Participants were recruited from outpatient academic medical centers.
PARTICIPANTS: Participants were enrolled in LEADS and diagnosed with amyloid-positive EOAD (n = 189) and amyloid-negative early-onset cognitive impairment not related to AD (EOnonAD; n = 43).
MEASUREMENT: 12-month reliable change (Z-scores) was compared between groups across cognitive domain composites, and distributions of individual participant trajectories were examined. Prediction of Z-scores by common AD biomarkers was also considered.
RESULTS: Both EOAD and EOnonAD displayed significantly lower 12-month follow-up scores than were predicted based on SRB equations, with declines more pronounced for EOAD across several domains. AD biomarkers of cerebral β-amyloid, tau, and EOAD-specific atrophy were predictive of 12-month change scores.
CONCLUSIONS: The current results support including EOAD patients in longitudinal clinical trials, and generate evidence of validation for using 12-month reliable cognitive change as a clinical outcome metric in clinical trials in EOAD cohorts like LEADS. Doing so will enhance the success of EOAD trials and permit a better understanding of individual responses to treatment.