A pre-pilot study on MRI CDM analysis for dementia

JRCT ID: jRCT1032210367

Registered date:05/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's disease, Frontotemporal lobar degeneration, No neurological disease
• Date of first enrollment: 05/10/2021
• Target sample size: 20
• Study type: Observational

Outcome(s)

• Primary Outcome: 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)
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients over 70 years of age attend NHO Niigata Hospital's outpatient clinic with Alzheimer's disease and frontotemporal lobar degeneration, and no neurological disease such as lumbar spondylosis, cervical spondylosis, muscle contraction headache, hypertension, hyperlipidemia.
2. Patients who wish to have a brain MRI scan.
3. Patients who have been or will be assessed by a speech-language pathologist or clinical psychologist for MMSE-J and MoCA-J.

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

Related Information

• Primary Sponsor: Nakajima Takashi