Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials

Iwatsubo, Takeshi; Iwata, Atsushi; Suzuki, Kazushi; Ihara, Ryoko; Arai, Hiroyuki; Ishii, Kenji; Senda, Michio; Ito, Kengo; Ikeuchi, Takeshi; Kuwano, Ryozo; Matsuda, Hiroshi; Sun, Chung-Kai; Beckett, Laurel A.; Petersen, Ronald C.; Weiner, Michael W.; Aisen, Paul S.; Donohue, Michael C.

doi:10.1016/j.jalz.2018.03.009

Cited by 95 publications

(115 citation statements)

References 26 publications

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“…Groups 2 and 3 had enough participants for statistical analyses, but female-dominant differences were observed in all groups. Total scores and subclassification domain items of the CogEvo, We also divided the total participants into three groups according to cut-off scores for the MMSE; that is, 24 and 26 points, which are commonly used to discriminate dementia from normal individuals, 2 and for registration criteria of the cognitively unimpaired (CU), 8,9 mild cognitive impairment (MCI) 10 and dementia (D) 11 in recent cohort studies, such as the Alzheimerʼs Disease Neuroimaging Initiative [12][13][14] and the Dominantly Inherited Alzheimer Network. 15 The numbers of participants, mean age, sex, and total and subclassified domain scores of CogEvo, MMSE scores and CDT scores are described in Table 1.…”

Section: Resultsmentioning

confidence: 99%

“…These findings suggest that the CogEvo test might also be feasible for preclinical observation studies or clinical trials for the prevention of dementia. In the MMSE, the range for the CU participants and participants with MCI was 24–30, and for mild Alzheimer's disease dementia the range was 20–26 . The CDR score and education duration‐dependent delayed recall score of the logical Memory II subscale for Wechsler Memory Scale‐Revised were additional criteria for discernment of CU, MCI and mild Alzheimer's disease dementia .…”

Section: Discussionmentioning

confidence: 99%

“…In the MMSE, the range for the CU participants and participants with MCI was 24-30, and for mild Alzheimer's disease dementia the range was 20-26. 12,13 The CDR score and education duration-dependent delayed recall score of the logical Memory II subscale for Wechsler Memory Scale-Revised were additional criteria for discernment of CU, MCI and mild Alzheimer's disease dementia. 10 For this reason, we validated whether the CogEvo test could separate cut-off points of 24 and 26 in MMSE scores.…”

Section: Discussionmentioning

confidence: 99%

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CogEvo, a cognitive function balancer, is a sensitive and easy psychiatric test battery for age‐related cognitive decline

Ichii

Nakamura

Kawarabayashi

et al. 2019

Geriatrics Gerontology Int

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Aim We examined whether a newly developed computer‐aided neuropsychiatric series of test, CogEvo, is necessary and sufficient for the evaluation of cognitive function in older people. Methods A total of 272 participants in worthwhile life activity for the prevention of decline in mobility and cognitive function were administered tests every week at 33 locations in Fukaura‐machi, Japan. Basic profile information, a Mini‐Mental State Examination (MMSE), a CogEvo and a clock drawing test were used in the present study. Results Our results are summarized as: (i) the total score of the CogEvo and MMSE tests decreased significantly according to age and in age group analysis; (ii) scores from the CogEvo and MMSE tests showed a significant correlation; (iii) MMSE scores showed marked ceiling effects; (iv) analysis of cognitive domains, such as orientation, attention, memory and executive function, and spatial cognition using CogEvo showed significant age‐dependent impairment; (v) CogEvo discriminated three score groups of MMSE results with sensitivity and specificity of 70% and 60% in the <23 score group, 78% and 54% in the 24–26 score group, and 85% and 70% in the >27 score group, respectively; (vi) CogEvo memory tests reflected more detailed recall function than registration function; and (vii) CogEvo spatial cognition test results were correlated with test items of the MMSE and clock drawing tests. Conclusions CogEvo is an easy and potentially useful computer‐aided test battery that can be used to evaluate age‐related or pathological decline in cognitive function from middle age and in preclinical stages of dementia. Geriatr Gerontol Int 2019; ••: ••–••.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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CogEvo, a cognitive function balancer, is a sensitive and easy psychiatric test battery for age‐related cognitive decline

Ichii

Nakamura

Kawarabayashi

et al. 2019

Geriatrics Gerontology Int

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“…The study protocol used in the J-ADNI has been described in detail elsewhere [3]. To describe the eligibility criteria briefly, CN participants in the J-ADNI were required to be 60 to 84 years of age, and have a physician's diagnosis of not having dementia or mild cognitive impairment, a CDR score of 0, and an MMSE score of 24 to 30 at the time of screening.…”

Section: Participants and Variables Analyzedmentioning

confidence: 99%

“…The Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) was the first large-scale longitudinal observational study in Japan, conducted between 2008 and 2014, following the North American ADNI (NA-ADNI), to elucidate the natural history of the early stages of AD in the Japanese population. We recently reported that individuals with mild cognitive impairment or mild AD exhibited similar profiles of cognitive and functional decline in the J-ADNI and the NA-ADNI [3]. The J-ADNI also included a 3-year follow-up with intensive assessments of 154 CN individuals from a total of 537 participants between 60 and 84 years of age.…”

Section: Introductionmentioning

confidence: 99%

Clinical and cognitive characteristics of preclinical Alzheimer's disease in the Japanese Alzheimer's Disease Neuroimaging Initiative cohort

Ihara

Iwata

Suzuki

et al. 2018

A&D Transl Res & Clin Interv

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IntroductionThe objective of this study was to determine the frequency and clinical and cognitive characteristics of preclinical Alzheimer's disease (AD) in a Japanese population to effectively design and conduct future preventive trials on preclinical AD.MethodsThree-year longitudinal data from cognitively normal participants who underwent cerebrospinal fluid biomarker measurement and/or amyloid positron emission tomography in the Japanese Alzheimer's Disease Neuroimaging Initiative, were analyzed. Comparisons between participants with and without amyloid β (Aβ) accumulation, and between those with and without elevated tau levels tau among participants with Aβ accumulation were performed.ResultsAmong 84 participants with available cerebrospinal fluid biomarker and/or amyloid positron emission tomography data, 19 (22.6%) exhibited Aβ accumulation. The frequency of APOE ε4 alleles was significantly higher in participants with Aβ accumulation. There were no significant differences in any of the cognitive tests at the baseline; however, participants with Aβ accumulation exhibited a decline in clock drawing test (linear mixed-effects model, P = .008) and a tendency toward loss of practice effects in the Mini-Mental State Examination and the logical memory over time. Although it did not reach statistical significance, the analysis indicated a decline in measurements of executive function over time in participants with elevated tau levels compared with those with normal tau levels.DiscussionThe frequency of preclinical AD in the Japanese Alzheimer's Disease Neuroimaging Initiative was lower than in similar studies because of the younger age of the participants and lower frequency of APOE ε4 carriage. Although limitations in sample size precluded definitive conclusions, the results suggest that even in the preclinical phase of AD, loss of practice effects in episodic memory tests and at a later stage, decline in executive function, are present. These findings may be useful for recruitment of individuals with preclinical AD and establishing a novel cognitive composite for use in clinical trials on preclinical AD.

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Efficacy and Safety of Cilostazol in Mild Cognitive Impairment

Saito,

Suzuki,

Ohtani

et al. 2023

JAMA Netw Open

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ImportanceRecent evidence indicates the efficacy of β-amyloid immunotherapy for the treatment of Alzheimer disease, highlighting the need to promote β-amyloid removal from the brain. Cilostazol, a selective type 3 phosphodiesterase inhibitor, promotes such clearance by facilitating intramural periarterial drainage.ObjectiveTo determine the safety and efficacy of cilostazol in mild cognitive impairment.Design, Setting, and ParticipantsThe COMCID trial (A Trial of Cilostazol for Prevention of Conversion from Mild Cognitive Impairment to Dementia) was an investigator-initiated, double-blind, phase 2 randomized clinical trial. Adult participants were registered between May 25, 2015, and March 31, 2018, and received placebo or cilostazol for up to 96 weeks. Participants were treated in the National Cerebral and Cardiovascular Center and 14 other regional core hospitals in Japan. Patients with mild cognitive impairment with Mini-Mental State Examination (MMSE) scores of 22 to 28 points (on a scale of 0 to 30, with lower scores indicating greater cognitive impairment) and Clinical Dementia Rating scores of 0.5 points (on a scale of 0, 0.5, 1, 2, and 3, with higher scores indicating more severe dementia) were enrolled. The data were analyzed from May 1, 2020, to December 1, 2020.InterventionsThe participants were treated with placebo, 1 tablet twice daily, or cilostazol, 50 mg twice daily, for up to 96 weeks.Main Outcomes and MeasuresThe primary end point was the change in the total MMSE score from baseline to the final observation. Safety analyses included all adverse events.ResultsThe full analysis set included 159 patients (66 [41.5%] male; mean [SD] age, 75.6 [5.2] years) who received placebo or cilostazol at least once. There was no statistically significant difference between the placebo and cilostazol groups for the primary outcome. The least-squares mean (SE) changes in the MMSE scores among patients receiving placebo were –0.1 (0.3) at the 24-week visit, –0.8 (0.3) at 48 weeks, –1.2 (0.4) at 72 weeks, and –1.3 (0.4) at 96 weeks. Among those receiving cilostazol, the least-squares mean (SE) changes in MMSE scores were –0.6 (0.3) at 24 weeks, –1.0 (0.3) at 48 weeks, –1.1 (0.4) at 72 weeks, and –1.8 (0.4) at 96 weeks. Two patients (2.5%) in the placebo group and 3 patients (3.8%) in the cilostazol group withdrew owing to adverse effects. There was 1 case of subdural hematoma in the cilostazol group, which may have been related to the cilostazol treatment; the patient was successfully treated surgically.Conclusions and RelevanceIn this randomized clinical trial, cilostazol was well tolerated, although it did not prevent cognitive decline. The efficacy of cilostazol should be tested in future trials.Trial RegistrationClinicalTrials.gov Identifier: NCT02491268

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Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials

Abstract: These results support the feasibility of bridging of clinical trials in the prodromal stage of AD between Asia and western countries.

Cited by 95 publications

References 26 publications

CogEvo, a cognitive function balancer, is a sensitive and easy psychiatric test battery for age‐related cognitive decline

CogEvo, a cognitive function balancer, is a sensitive and easy psychiatric test battery for age‐related cognitive decline

Clinical and cognitive characteristics of preclinical Alzheimer's disease in the Japanese Alzheimer's Disease Neuroimaging Initiative cohort

Efficacy and Safety of Cilostazol in Mild Cognitive Impairment

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