Document Detail


Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects.
MedLine Citation:
PMID:  10714659     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the rate of brain atrophy calculated from serial magnetic resonance imaging (MRI) registration as a surrogate marker of disease progression for use in clinical trials in Alzheimer disease (AD). METHODS: Eighteen patients with mild to moderate AD and 18 age-matched normal controls underwent 2 MRI brain scans separated by a 12-month interval. Each individual's later scan was registered to their first scan, and the volume of cerebral tissue loss calculated directly from the registered and subtracted MRI scan pairs. The mean and SD of the rate of brain volume changes were used to estimate the sample sizes that would be needed in a clinical trial with a drug anticipated to modify disease progression by varying degrees. Comparable sample size estimates were performed with data for other methods of monitoring rates of brain atrophy, extracted from published papers. RESULTS: The mean (SD) rate of brain atrophy for the patients with AD was 2.37% (1.11%) per year, while in the control group it was 0.41% (0.47%) per year. Based on these figures, to have 90% power to detect a drug effect equivalent to a 20% reduction in the rate of atrophy, 207 patients would be needed in each treatment arm. This assumes a 1-year placebo-controlled trial with a 10% patient dropout rate, and that 10% of scan pairs are unusable. CONCLUSION: Registration of serial MRI volume images provides a powerful method of quantification of brain atrophy that can be used to monitor progression of AD in clinical trials.
Authors:
N C Fox; S Cousens; R Scahill; R J Harvey; M N Rossor
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of neurology     Volume:  57     ISSN:  0003-9942     ISO Abbreviation:  Arch. Neurol.     Publication Date:  2000 Mar 
Date Detail:
Created Date:  2000-03-23     Completed Date:  2000-03-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372436     Medline TA:  Arch Neurol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  339-44     Citation Subset:  AIM; IM    
Affiliation:
Department of Clinical Neurology, Institute of Neurology, London, England.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Alzheimer Disease / diagnosis*,  pathology
Atrophy
Brain / pathology*
Case-Control Studies
Female
Humans
Magnetic Resonance Imaging / statistics & numerical data
Male
Middle Aged
Registries*
Sample Size
Sensitivity and Specificity
Treatment Outcome
Comments/Corrections
Comment In:
Arch Neurol. 2000 Mar;57(3):312-4   [PMID:  10714654 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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