臨床研究等提出・公開システム

An exploratory pre-pilot study on cortical disarray measurement(CDM) analysis methods for dementia

A pre-pilot study on MRI CDM analysis for dementia

Nakajima Takashi

National Hospital Organization Niigata National Hospital

3-52 Akasakacho Kashiwazaki city

nakajima-md@mqb.biglobe.ne.jp

Nakajima Takashi

National Hospital Organization Niigata National Hospital

3-52 Akasakacho Kashiwazaki city

+81-257-30-8806

225-kenkyuu@mail.hosp.go.jp

Recruiting

Oct. 05, 2021

Observational

1. Patients aged 70 years or older with Alzheimer disease or frontotemporal lobar degeneration and patients aged 65 years or older with no neurological diseases such as lumbar spondylosis, cervical spondylosis, muscle contraction headache, hypertension, or hyperlipidemia who are attending the outpatient clinic of NHO Niigata National Hospital.
2. Patients who wish to undergo a brain MRI scan.
3. Patients who have been or will be assessed by a speech-language pathologist or clinical psychologist using MMSE-J and MoCA-J.

Patients who have been diagnosed with any neurodegenerative disease, cerebrovascular disease, and other severe diseases.

Both

Alzheimer's disease, Frontotemporal lobar degeneration, No neurological disease

To confirm that MRI DTI30+, 3D T1 images and clinical data taken at a Japanese dementia clinic after the patient's IC are uploaded easily and safely to OBD in the UK for CDM analysis. (OBD stands for Oxford Brain Diagnostics Ltd that is a company registered in England and Wales. Registered No. 11703979 Oxford Centre for Innovation, New Road, Oxford, OX1 1BY)

To confirm that OBD can adjust and select the measurement parameters so that the CDM analysis is performed for disease and severity discriminant purposes using clinical data (age, gender, clinical diagnosis, disease duration, MMSE-J score, and MoCA-J score). To obtain information that will enable us to interpret CDM measurement parameters, and apply discriminant models, and discriminant formulae for use in the next pilot study, and to predict the number of cases in the next pilot study in order to validate further use of CDM.

+81-257-22-2126

July. 01, 2021

Yes

Individual participant-level data (IPD) generated in this study will be managed according to the purpose of data use. Data provided to the imaging analysis contractor, Oxford Brain Diagnostics Ltd, will be pseudonymized, with all directly identifiable information removed before transfer. The correspondence table linking pseudonymized data to participants will be securely maintained at the study site, and no identifying information will be accessible to the contractor. When research data are shared for the advancement of medical research and research transparency, only anonymized IPD that cannot directly or indirectly identify participants will be shared. The shared data may include MRI imaging data, CDM-derived parameters, and selected clinical variables. The anonymized IPD may be shared with academic institutions, research organizations, and industry researchers in Japan and internationally. When data are shared with overseas institutions, only anonymized data will be provided and handled with consideration for international data protection regulations, including GDPR. Data sharing and secondary use will follow the Ethical Guidelines for Medical and Biological Research Involving Human Subjects in Japan, and if re-consent is impracticable, study information will be disclosed and an opt-out opportunity will be provided.

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