Twelve-month metabolic declines in probable Alzheimer's disease and amnestic mild cognitive impairment assessed using an empirically pre-defined statistical region-of-interest: Findings from the Alzheimer's Disease Neuroimaging Initiative

Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-mont...

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Published in	NeuroImage (Orlando, Fla.) Vol. 51; no. 2; pp. 654 - 664
Main Authors	Chen, Kewei, Langbaum, Jessica B.S., Fleisher, Adam S., Ayutyanont, Napatkamon, Reschke, Cole, Lee, Wendy, Liu, Xiaofen, Bandy, Dan, Alexander, Gene E., Thompson, Paul M., Foster, Norman L., Harvey, Danielle J., de Leon, Mony J., Koeppe, Robert A., Jagust, William J., Weiner, Michael W., Reiman, Eric M.
Format	Journal Article
Language	English
Published	United States Elsevier Inc 01.06.2010 Elsevier Limited
Subjects	Aged Algorithms Alzheimer Disease - diagnostic imaging Alzheimer Disease - pathology Alzheimer's disease Biomarkers Brain - diagnostic imaging Brain - pathology Brain Mapping - methods Clinical trials Cognition Disorders - diagnostic imaging Cognition Disorders - pathology Cognitive ability Disease Progression Female Humans Longitudinal Studies Male Medical imaging Multicenter Studies as Topic Pathology Positron-Emission Tomography Randomized Controlled Trials as Topic Research Design Studies
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Abstract	Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-month CMRgl declines in 69 probable AD patients, 154 amnestic mild cognitive impairment (MCI) patients, and 79 cognitively normal controls (NCs) from the AD Neuroimaging Initiative (ADNI) using statistical parametric mapping (SPM). We introduce the use of an empirically pre-defined statistical region-of-interest (sROI) to characterize CMRgl declines with optimal power and freedom from multiple comparisons, and we estimate the number of patients needed to characterize AD-slowing treatment effects in multi-center randomized clinical trials (RCTs). The AD and MCI groups each had significant twelve-month CMRgl declines bilaterally in posterior cingulate, medial and lateral parietal, medial and lateral temporal, frontal and occipital cortex, which were significantly greater than those in the NC group and correlated with measures of clinical decline. Using sROIs defined based on training sets of baseline and follow-up images to assess CMRgl declines in independent test sets from each patient group, we estimate the need for 66 AD patients or 217 MCI patients per treatment group to detect a 25% AD-slowing treatment effect in a twelve-month, multi-center RCT with 80% power and two-tailed alpha=0.05, roughly one-tenth the number of the patients needed to study MCI patients using clinical endpoints. Our findings support the use of FDG PET, brain-mapping algorithms and empirically pre-defined sROIs in RCTs of AD-slowing treatments.
AbstractList	Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-month CMRgl declines in 69 probable AD patients, 154 amnestic mild cognitive impairment (MCI) patients, and 79 cognitively normal controls (NCs) from the AD Neuroimaging Initiative (ADNI) using statistical parametric mapping (SPM). We introduce the use of an empirically pre-defined statistical region-of-interest (sROI) to characterize CMRgl declines with optimal power and freedom from multiple comparisons, and we estimate the number of patients needed to characterize AD-slowing treatment effects in multi-center randomized clinical trials (RCTs). The AD and MCI groups each had significant twelve-month CMRgl declines bilaterally in posterior cingulate, medial and lateral parietal, medial and lateral temporal, frontal and occipital cortex, which were significantly greater than those in the NC group and correlated with measures of clinical decline. Using sROIs defined based on training sets of baseline and follow-up images to assess CMRgl declines in independent test sets from each patient group, we estimate the need for 66 AD patients or 217 MCI patients per treatment group to detect a 25% AD-slowing treatment effect in a twelve-month, multi-center RCT with 80% power and two-tailed alpha=0.05, roughly one-tenth the number of the patients needed to study MCI patients using clinical endpoints. Our findings support the use of FDG PET, brain-mapping algorithms and empirically pre-defined sROIs in RCTs of AD-slowing treatments. Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-month CMRgl declines in 69 probable AD patients, 154 amnestic mild cognitive impairment (MCI) patients, and 79 cognitively normal controls (NCs) from the AD Neuroimaging Initiative (ADNI) using statistical parametric mapping (SPM). We introduce the use of an empirically predefined statistical region-of-interest (sROI) to characterize CMRgl declines with optimal power and freedom from multiple comparisons, and we estimate the number of patients needed to characterize AD-slowing treatment effects in multi-center randomized clinical trials (RCTs). The AD and MCI groups each had significant twelve-month CMRgl declines bilaterally in posterior cingulate, medial and lateral parietal, medial and lateral temporal, frontal and occipital cortex, which were significantly greater than those in the NC group and correlated with measures of clinical decline. Using sROIs defined based on training sets of baseline and follow-up images to assess CMRgl declines in independent test sets from each patient group, we estimate the need for 66 AD patients or 217 MCI patients per treatment group to detect a 25% AD-slowing treatment effect in a twelve-month, multi-center RCT with 80% power and two-tailed alpha=0.05, roughly one-tenth the number of the patients needed to study MCI patients using clinical endpoints. Our findings support the use of FDG PET, brain-mapping algorithms and empirically pre-defined sROIs in RCTs of AD-slowing treatments. Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-month CMRgl declines in 69 probable AD patients, 154 amnestic mild cognitive impairment (MCI) patients, and 79 cognitively normal controls (NCs) from the AD Neuroimaging Initiative (ADNI) using statistical parametric mapping (SPM). We introduce the use of an empirically pre-defined statistical region-of-interest (sROI) to characterize CMRgl declines with optimal power and freedom from multiple comparisons, and we estimate the number of patients needed to characterize AD-slowing treatment effects in multi-center randomized clinical trials (RCTs). The AD and MCI groups each had significant twelve-month CMRgl declines bilaterally in posterior cingulate, medial and lateral parietal, medial and lateral temporal, frontal and occipital cortex, which were significantly greater than those in the NC group and correlated with measures of clinical decline. Using sROIs defined based on training sets of baseline and follow-up images to assess CMRgl declines in independent test sets from each patient group, we estimate the need for 66 AD patients or 217 MCI patients per treatment group to detect a 25% AD-slowing treatment effect in a twelve-month, multi-center RCT with 80% power and two-tailed alpha=0.05, roughly one-tenth the number of the patients needed to study MCI patients using clinical endpoints. Our findings support the use of FDG PET, brain-mapping algorithms and empirically pre-defined sROIs in RCTs of AD-slowing treatments.Alzheimer's disease (AD) is characterized by specific and progressive reductions in fluorodeoxyglucose positron emission tomography (FDG PET) measurements of the cerebral metabolic rate for glucose (CMRgl), some of which may precede the onset of symptoms. In this report, we describe twelve-month CMRgl declines in 69 probable AD patients, 154 amnestic mild cognitive impairment (MCI) patients, and 79 cognitively normal controls (NCs) from the AD Neuroimaging Initiative (ADNI) using statistical parametric mapping (SPM). We introduce the use of an empirically pre-defined statistical region-of-interest (sROI) to characterize CMRgl declines with optimal power and freedom from multiple comparisons, and we estimate the number of patients needed to characterize AD-slowing treatment effects in multi-center randomized clinical trials (RCTs). The AD and MCI groups each had significant twelve-month CMRgl declines bilaterally in posterior cingulate, medial and lateral parietal, medial and lateral temporal, frontal and occipital cortex, which were significantly greater than those in the NC group and correlated with measures of clinical decline. Using sROIs defined based on training sets of baseline and follow-up images to assess CMRgl declines in independent test sets from each patient group, we estimate the need for 66 AD patients or 217 MCI patients per treatment group to detect a 25% AD-slowing treatment effect in a twelve-month, multi-center RCT with 80% power and two-tailed alpha=0.05, roughly one-tenth the number of the patients needed to study MCI patients using clinical endpoints. Our findings support the use of FDG PET, brain-mapping algorithms and empirically pre-defined sROIs in RCTs of AD-slowing treatments.
Author	Alexander, Gene E. Jagust, William J. Ayutyanont, Napatkamon Fleisher, Adam S. Harvey, Danielle J. Chen, Kewei Reschke, Cole Langbaum, Jessica B.S. Foster, Norman L. Reiman, Eric M. Bandy, Dan Liu, Xiaofen Koeppe, Robert A. Weiner, Michael W. Thompson, Paul M. de Leon, Mony J. Lee, Wendy
AuthorAffiliation	1 Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ 2 Department of Mathematics and Statistics, Arizona State University, Tempe, AZ 7 Division of Biostatistics, Department of Public Health Sciences, University of California, Davis 15 Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ 17 Arizona Alzheimer's Consortium, Phoenix, AZ 9 The Nathan Kline Institute, Orangeburg NY 14 Psychiatry, University of California San Francisco, San Francisco, CA 11 School of Public Health and Helen Wills Neuroscience Institute, University of California Berkeley, Berkeley, CA 5 Laboratory of Neuro Imaging, Department of Neurology, UCLA School of Medicine, Los Angeles, CA 6 Center for Alzheimer's Care, Imaging and Research and Department of Neurology, University of Utah, Salt Lake City, UT 16 Department of Neurosciences, University of California, San Diego 10 Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, MI 12 Depa
AuthorAffiliation_xml	– name: 9 The Nathan Kline Institute, Orangeburg NY – name: 14 Psychiatry, University of California San Francisco, San Francisco, CA – name: 16 Department of Neurosciences, University of California, San Diego – name: 4 Department of Psychiatry, University of Arizona, Tucson, AZ – name: 13 Medicine, University of California San Francisco, San Francisco, CA – name: 5 Laboratory of Neuro Imaging, Department of Neurology, UCLA School of Medicine, Los Angeles, CA – name: 1 Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ – name: 10 Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, MI – name: 6 Center for Alzheimer's Care, Imaging and Research and Department of Neurology, University of Utah, Salt Lake City, UT – name: 12 Department of Radiology, University of California San Francisco, San Francisco, CA – name: 2 Department of Mathematics and Statistics, Arizona State University, Tempe, AZ – name: 11 School of Public Health and Helen Wills Neuroscience Institute, University of California Berkeley, Berkeley, CA – name: 17 Arizona Alzheimer's Consortium, Phoenix, AZ – name: 3 Department of Psychology and Evelyn F. McKnight Brain Institute, University of Arizona, Tucson, AZ – name: 15 Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ – name: 7 Division of Biostatistics, Department of Public Health Sciences, University of California, Davis – name: 8 Center for Brain Health, Department of Psychiatry, Langone Medical Center, New York University
Author_xml	– sequence: 1 givenname: Kewei surname: Chen fullname: Chen, Kewei email: Kewei.Chen@bannerhealth.com organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 2 givenname: Jessica B.S. surname: Langbaum fullname: Langbaum, Jessica B.S. organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 3 givenname: Adam S. surname: Fleisher fullname: Fleisher, Adam S. organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 4 givenname: Napatkamon surname: Ayutyanont fullname: Ayutyanont, Napatkamon organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 5 givenname: Cole surname: Reschke fullname: Reschke, Cole organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 6 givenname: Wendy surname: Lee fullname: Lee, Wendy organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 7 givenname: Xiaofen surname: Liu fullname: Liu, Xiaofen organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 8 givenname: Dan surname: Bandy fullname: Bandy, Dan organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA – sequence: 9 givenname: Gene E. surname: Alexander fullname: Alexander, Gene E. organization: Department of Psychology and Evelyn F. McKnight Brain Institute, Tucson, AZ, USA – sequence: 10 givenname: Paul M. surname: Thompson fullname: Thompson, Paul M. organization: Laboratory of Neuro Imaging, Department of Neurology, UCLA School of Medicine, Los Angeles, CA, USA – sequence: 11 givenname: Norman L. surname: Foster fullname: Foster, Norman L. organization: Center for Alzheimer's Care, Imaging and Research and Department of Neurology, University of Utah, Salt Lake City, UT, USA – sequence: 12 givenname: Danielle J. surname: Harvey fullname: Harvey, Danielle J. organization: Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, USA – sequence: 13 givenname: Mony J. surname: de Leon fullname: de Leon, Mony J. organization: Center for Brain Health, Department of Psychiatry, Langone Medical Center, New York University, USA – sequence: 14 givenname: Robert A. surname: Koeppe fullname: Koeppe, Robert A. organization: Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, MI, USA – sequence: 15 givenname: William J. surname: Jagust fullname: Jagust, William J. organization: School of Public Health and Helen Wills Neuroscience Institute, University of California Berkeley, Berkeley, CA, USA – sequence: 16 givenname: Michael W. surname: Weiner fullname: Weiner, Michael W. organization: Department of Radiology, University of California San Francisco, San Francisco, CA, USA – sequence: 17 givenname: Eric M. surname: Reiman fullname: Reiman, Eric M. organization: Banner Alzheimer's Institute and Banner Good Samaritan PET Center, Phoenix, AZ, USA
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/20202480$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Copyright	2010 Elsevier Inc. Copyright 2010 Elsevier Inc. All rights reserved. Copyright Elsevier Limited Jun 1, 2010
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CorporateAuthor	The Alzheimer's Disease Neuroimaging Initiative Alzheimer's Disease Neuroimaging Initiative
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Data used in this article were obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database (www.loni.ucla.edu/ADNI). ADNI investigators other than those listed above contributed to study design, implementation or data provision but did not participate in the analyses or writing of this report. The complete listing of ADNI investigators is available at http://www.loni.ucla.edu/ADNI/Data/ADNI_Authorship_List.pdf.
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SubjectTerms	Aged Algorithms Alzheimer Disease - diagnostic imaging Alzheimer Disease - pathology Alzheimer's disease Biomarkers Brain - diagnostic imaging Brain - pathology Brain Mapping - methods Clinical trials Cognition Disorders - diagnostic imaging Cognition Disorders - pathology Cognitive ability Disease Progression Female Humans Longitudinal Studies Male Medical imaging Multicenter Studies as Topic Pathology Positron-Emission Tomography Randomized Controlled Trials as Topic Research Design Studies
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Title	Twelve-month metabolic declines in probable Alzheimer's disease and amnestic mild cognitive impairment assessed using an empirically pre-defined statistical region-of-interest: Findings from the Alzheimer's Disease Neuroimaging Initiative
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