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Inclusion criteria provide heterogeneity in baseline profiles of patients with mild cognitive impairment: comparison of two prospective cohort studies
  1. Shoji Kawashima1,2,
  2. Kengo Ito1,
  3. Takashi Kato1,
  4. the SEAD-J Study Group*
  1. 1Department of Clinical and Experimental Neuroimaging, Center for Development of Advanced Medicine for Dementia, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan
  2. 2Department of Neurology, Nagoya City University Graduate School of Medical Science, Nagoya, Japan
  1. Correspondence to Dr Kengo Ito; kito{at}ncgg.go.jp

Abstract

Background Mild cognitive impairment (MCI) is considered to represent a transitional stage between ageing and Alzheimer's disease (AD). To aim at identifying neuroimaging measures associated with cognitive changes in healthy elderly and MCI patients, longitudinal multicentre studies are ongoing in several countries. The patient profiles of each study are based on unique inclusion criteria.

Objectives The purpose of the study is to clarify differences in baseline profiles of MCI patients between Studies on Diagnosis of Early Alzheimer's Disease—Japan (SEAD-J) and Alzheimer's Disease Neuroimaging Initiative (ADNI) and to examine the association between baseline profiles and risk of early conversion to AD.

Design Prospective cohort study.

Setting and participants SEAD-J recruited 114 patients from nine facilities in Japan. A total of 200 patients in ADNI with fluorodeoxyglucose–positron emission tomography (FDG-PET) were enrolled from the USA.

Methods Baseline profiles were statistically analysed. For FDG-PET at a time of inclusion, associations between each profile and cerebral metabolic rate for glucose (CMRgl) were examined using SPM5 software. In each study, the ratio of conversion to AD within the 1-year and 2-year period after inclusion was investigated and differences in baseline profiles between AD converters and non-converters were analysed.

Results SEAD-J included MCI patients with more severe verbal memory deficits and extracted patients with higher depressive tendencies. These differences were likely to be associated with criteria. SEAD-J exhibited a higher rate of conversion within 1 year compared with ADNI (24.5% vs 13.5%). In FDG-PET analyses of SEAD-J, AD converters within 1 year showed more severe decrease of FDG uptake in bilateral inferior parietal regions compared with non-converters.

Conclusions Different inclusion criteria provided differences in baseline profiles. The severity of memory deficit might cause increase of the AD conversion within 1 year. Clinical outcomes of multicentre studies for early diagnosis of AD should be interpreted carefully considering profiles of patients.

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Footnotes

  • * Research group of the Studies on Diagnosis of Early Alzheimer's Disease—Japan (SEAD-J) comprised investigators from nine different facilities. The investigators contributed to the design and implementation of SEAD-J and/or provided data but did not participate in the analyses of this report.

  • To cite: Kawashima S, Ito K, Kato T, et al. Inclusion criteria provide heterogeneity in baseline profiles of patients with mild cognitive impairment: comparison of two prospective cohort studies. BMJ Open 2012;2:e000773. doi:10.1136/bmjopen-2011-000773

  • Contributors The investigators within ADNI contributed to the design and implementation of ADNI and/or provided data but did not participate in the analysis or writing of this report. We had completely followed the review for ADNI Publications Policy. ADNI DPC approved it as acceptable for submission to a journal.

  • Funding SEAD-J was supported by the Health Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan (H17-Tyojyu-023) and the Research Funding for Longevity Sciences from National Center for Geriatrics and Gerontology, Japan.

  • Competing interests None.

  • Ethics approval SEAD-J was approved by the medical ethics committee of the Center for Development of Advanced Medicine for Dementia, National Center for Geriatrics and Gerontology.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data available.

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