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Function and clinical meaningfulness of treatments for mild Alzheimer's disease.

ABSTRACT: INTRODUCTION:Effectiveness of Alzheimer's disease (AD) treatments is commonly evaluated with coprimary outcomes; cognition with function to ensure clinical meaningfulness of a cognitive effect. METHODS:We reviewed the literature for functional outcomes in mild AD or mild cognitive impairment (MCI) patients (distinct from combined mild-moderate/severe AD) treated with approved AD drugs. Cognitive and functional treatment differences in mild AD patients in solanezumab EXPEDITION/EXPEDITION2 studies were compared across time. RESULTS:Seven publications provided MCI/mild AD functional outcomes, one of which reported a significant functional treatment effect. Secondary analyses of EXPEDITION studies suggested a smaller functional effect of solanezumab relative to cognition. An increasing effect of solanezumab over 18 months was shown for cognition and function. DISCUSSION:Function as the sole measure to demonstrate clinical meaningfulness of cognitive effects in mild AD may have limitations. For disease-modifying treatments, point differences on cognitive and functional scales should be qualified with duration of treatment.

SUBMITTER: Siemers E

PROVIDER: S-EPMC4879645 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Function and clinical meaningfulness of treatments for mild Alzheimer's disease.

Siemers Eric E Holdridge Karen Chilcott KC Sundell Karen L KL Liu-Seifert Hong H

Alzheimer's & dementia (Amsterdam, Netherlands) 20160310

<h4>Introduction</h4>Effectiveness of Alzheimer's disease (AD) treatments is commonly evaluated with coprimary outcomes; cognition with function to ensure clinical meaningfulness of a cognitive effect.<h4>Methods</h4>We reviewed the literature for functional outcomes in mild AD or mild cognitive impairment (MCI) patients (distinct from combined mild-moderate/severe AD) treated with approved AD drugs. Cognitive and functional treatment differences in mild AD patients in solanezumab EXPEDITION/EXP ...[more]

PMID: 27239541

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Project description:BACKGROUND:Studies suggest a role of the innate immune system, including the activity of neutrophils, in neurodegeneration related to Alzheimer's disease (AD), but prospective cognitive data remain lacking in humans. We aimed to investigate the predictive relationship between neutrophil-associated inflammatory proteins in peripheral blood and changes in memory and executive function over 1?year in patients with AD. METHODS:Participants with AD were identified from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Neutrophil gelatinase-associated lipocalin (NGAL), myeloperoxidase (MPO), interleukin-8 (IL-8), macrophage inflammatory protein-1 beta (MIP-1?), and tumor necrosis factor (TNF) were assayed by luminex immunofluorescence multiplex assay at baseline. Confirmatory factor analysis was used to test an underlying neutrophil associated plasma inflammatory factor. Composite z-scores for memory and executive function were generated from multiple tests at baseline and at 1?year. A multiple linear regression model was used to investigate the association of the baseline inflammatory factor with changes in memory and executive function over 1?year. RESULTS:Among AD patients (n?=?109, age?=?74.8?±?8.1, 42% women, Mini Mental State Examination [MMSE]?=?23.6?±?1.9), the neutrophil-related inflammatory proteins NGAL (??=?0.595, p?<?.001), MPO (??=?0.575, p?<?.001), IL-8 (??=?0.525, p?<?.001), MIP-1? (??=?0.411, p?=?.008), and TNF (??=?0.475, p?<?.001) were found to inform an underlying factor. Over 1?year, this inflammatory factor predicted a decline in executive function (??=?-?0.152, p?=?0.015) but not memory (??=?0.030, p?=?0.577) in models controlling for demographics, brain atrophy, white matter hyperintensities, the ApoE ?4 allele, concomitant medications, and baseline cognitive performance. CONCLUSIONS:An inflammatory factor constructed from five neutrophil-related markers in peripheral blood predicted a decline in executive function over 1?year in people with mild AD.

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Function and clinical meaningfulness of treatments for mild Alzheimer's disease.

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Function and clinical meaningfulness of treatments for mild Alzheimer's disease.

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