Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.
Alzheimer Dis Assoc Disord
; 29(2): 101-9, 2015.
Article
in En
| MEDLINE
| ID: mdl-25437302
ABSTRACT
BACKGROUND:
The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI).METHODS:
Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aß1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms.RESULTS:
Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency.CONCLUSION:
These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Brain
/
Cognition
/
Alzheimer Disease
/
Cognitive Dysfunction
/
Hippocampus
Type of study:
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Language:
En
Journal:
Alzheimer Dis Assoc Disord
Journal subject:
NEUROLOGIA
/
PSIQUIATRIA
Year:
2015
Type:
Article