1. Effect of Amyloid Imaging on the Diagnosis and Management of Patients with Cognitive Decline: Impact of Appropriate Use Criteria.

    Dementia and Geriatric Cognitive Disorders 41(1-2):80 (2016) PMID 26745445

    Published appropriate use criteria (AUC) describe patients for whom amyloid positron emission tomography (PET) might be most useful. This study compared the impact of amyloid PET on diagnosis and management in subjects likely to either meet or not meet AUC. Physicians provided a provisional diag...
  2. Amyloid-β 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials.

    Neurology 85(8):692 (2015) PMID 26208959 PMCID PMC4553028

    To evaluate the effects of bapineuzumab on brain β-amyloid (Aβ) burden using (11)C-Pittsburgh compound B ((11)C-PiB)-PET. Two phase 3 clinical trials, 1 each in apolipoprotein APOE ε4 carriers and noncarriers, were conducted in patients with mild to moderate Alzheimer disease dementia. Bapineuzu...
  3. Changes in Brain Volume with Bapineuzumab in Mild to Moderate Alzheimer's Disease.

    Journal of Alzheimer's Disease 49(4):1123 (2015) PMID 26639957

    Bapineuzumab, an anti-amyloid-β monoclonal antibody, was evaluated in two placebo-controlled trials in APOE*ɛ4 carriers and noncarriers, respectively, with Alzheimer's disease. A volumetric magnetic resonance imaging substudy was performed to determine if bapineuzumab altered brain volume rate o...
  4. Assessing cognition and function in Alzheimer's disease clinical trials: do we have the right tools?

    Alzheimer's & Dementia 10(6):853 (2014) PMID 25458309

    Several lines of evidence from Alzheimer's disease (AD) research continue to support the notion that the biological changes associated with AD are occurring possibly several decades before an individual will experience the cognitive and functional changes associated with the disease. The Nationa...
  5. Understanding the relative importance of preserving functional abilities in Alzheimer's disease in the United States and Germany.

    Quality of Life Research 23(6):1813 (2014) PMID 24448684

    To estimate the relative importance that Alzheimer's disease (AD) caregivers in the United States and Germany place on preserving patients' ability to perform activities of daily living. US and German residents providing care for a person with AD completed an online preference survey. Each respo...

    Alzheimer's & Dementia 10(4):P248 (2014)

  7. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease.

    New England Journal of Medicine 370(4):322 (2014) PMID 24450891 PMCID PMC4159618

    Bapineuzumab, a humanized anti-amyloid-beta monoclonal antibody, is in clinical development for the treatment of Alzheimer's disease. We conducted two double-blind, randomized, placebo-controlled, phase 3 trials involving patients with mild-to-moderate Alzheimer's disease--one involving 1121 car...
  8. Cognition in MCI and Alzheimer's disease: baseline data from a longitudinal study of the NTB.

    Clinical Neuropsychologist 28(2):252 (2014) PMID 24521259

    Baseline data are summarized from a study examining the psychometric properties of the Neuropsychological Test Battery (NTB) and its subtests, and correlating the NTB with other cognitive and functional assessments. A multicenter, longitudinal, non-interventional study included mild to moderate ...
  9. Effect of bapineuzumab on CSF p-tau and t-tau in mild-to-moderate Alzheimer's disease: Results from two phase III trials in APOE-ε4 carriers and noncarriers

    Alzheimer's & Dementia 9(4):P138 (2013)

  10. Designing drug trials for Alzheimer's disease: what we have learned from the release of the phase III antibody trials: a report from the EU/US/CTAD Task Force.

    Alzheimer's & Dementia 9(4):438 (2013) PMID 23809364

    An international task force of investigators from academia, industry, nonprofit foundations, and regulatory agencies met in Monte Carlo, Monaco, on October 31, 2012, to review lessons learned from the recent bapineuzumab and solanezumab trials, and to incorporate insights gained from these trial...
  11. Evaluation of the pons as a reference region for amyloid PET in Alzheimer's disease clinical trials

    Alzheimer's & Dementia 9(4):P18 (2013)

  12. Correlation of brain atrophy with clinical progression in mild-to-moderate Alzheimer's disease: Results from the volumetric MRI substudies of two phase III trials with bapineuzumab

    Alzheimer's & Dementia 9(4):P289 (2013)

  13. The rate of clinical progression and brain atrophy is greater with increasing severity of Alzheimer's disease: Results from the volumetric MRI substudies of two phase III trials with bapineuzumab

    Alzheimer's & Dementia 9(4):P287 (2013)

  14. Amyloid deposition detected with florbetapir F 18 ((18)F-AV-45) is related to lower episodic memory performance in clinically normal older individuals.

    Neurobiology of Aging 34(3):822 (2013) PMID 22878163 PMCID PMC3518678

    The objective of this study was to evaluate the relationship of amyloid burden, as assessed by florbetapir F 18 ((18)F-AV-45) amyloid positron emission tomography, and cognition in healthy older control (HC) subjects. Seventy-eight HC subjects were assessed with a brief cognitive test battery an...
  15. The ADAS-Cog revisited: novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials.

    Alzheimer's & Dementia 9(1 Suppl):S21 (2013) PMID 23127469 PMCID PMC3732822

    The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) has been used widely as a cognitive end point in Alzheimer's Disease (AD) clinical trials. Efforts to treat AD pathology at earlier stages have also used ADAS-Cog, but failure in these trials can be difficult to interpret because the ...
  16. Rationale for use of the Clinical Dementia Rating Sum of Boxes as a primary outcome measure for Alzheimer's disease clinical trials.

    Alzheimer's & Dementia 9(1 Suppl):S45 (2013) PMID 22658286

    We used the database of the Alzheimer's Disease Neuroimaging Initiative (ADNI) to explore the psychometric properties of the Clinical Dementia Rating Sum of Boxes (CDR-SB) to consider its utility as an outcome measure for clinical trials in early and mild, as well as later, stages of Alzheimer's...
  17. Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline.

    Alzheimer Disease and Associated Disorders 27(1):4 (2013) PMID 23203162

    Florbetapir F18 has been approved by the Food and Drug Administration for in vivo assessment of amyloid pathology in patients undergoing evaluation for Alzheimer disease (AD). The aim of this study was to determine the impact of amyloid imaging on the diagnoses and management of patients undergo...
  18. Improving Alzheimer's disease phase II clinical trials.

    Alzheimer's & Dementia 9(1):39 (2013) PMID 23164548

    Over the past 30 years, many drugs have been studied as possible treatments for Alzheimer's disease, but only four have demonstrated sufficient efficacy to be approved as treatments, of which three are in the same class. This lack of success has raised questions both in the pharmaceutical indust...
  19. Amyloid-β assessed by florbetapir F 18 PET and 18-month cognitive decline: a multicenter study.

    Neurology 79(16):1636 (2012) PMID 22786606 PMCID PMC3468774

    Florbetapir F 18 PET can image amyloid-β (Aβ) aggregates in the brains of living subjects. We prospectively evaluated the prognostic utility of detecting Aβ pathology using florbetapir PET in subjects at risk for progressive cognitive decline. A total of 151 subjects who previously participated ...
  20. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease.

    Archives of Neurology 69(8):1002 (2012) PMID 22473769

    Given the slow and variable clinical course of Alzheimer disease, very large and extended clinical trials are needed to identify a beneficial clinical effect of disease-modifying treatments. Therefore, biomarkers are essential to prove that an anti-β-amyloid (Aβ) drug candidate affects both Aβ m...