Observational Study on New MR Biomarkers for Alzheimer's Disease and Real-World Survey on Lecanemab Treatment in a Super-Aged Society

JRCT ID: jRCT1031240123

Registered date:28/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild Alzheimer's disease
• Date of first enrollment: 26/05/2024
• Study type: Observational

Outcome(s)

• Primary Outcome: The primary endpoint will be the variables or computed values of these variables obtained from the Cortical Disarray Measurement (CDM), analyzed based on 32-direction Diffusion Tensor Imaging (32DTI) from standard clinical MRI. These measurements and analyses will be conducted by our collaborators at Oxford Brain Diagnostics Ltd, Oxford Centre for Innovation, Oxford, UK.
• Secondary Outcome: The baseline and secondary evaluation items are as follows: age, gender, height and weight, ApoE genotype (not tested in this study, but will be collected if tested outside of this study), months from onset to diagnosis, months from diagnosis to consent, years of education since elementary school, presence or absence of BPSD (if present, specify), presence or absence of AD medications (if present, specify), presence or absence of complications (if present, specify), presence or absence of past medical history (if present, specify). Brain MRI findings must be consistent with AD within the inclusion criteria. Record the presence or absence of the following abnormal MRI findings: brain contusion, cerebral aneurysm, vascular malformation, brain infection, multiple lacunar infarcts, stroke in major vessel territories, small vessel disease/white matter changes, brain tumours (including meningioma and arachnoid cysts). CSF test data (phosphorylated tau pg/ml, beta-amyloid 42/40 ratio < 0.067, beta-amyloid 42 pg/ml, beta-amyloid 40 pg/ml) or Amyloid PET data (positive or negative), MMSE-J, CDR Global score, CDR-SB score (0-18), and the Lawton Instrumental Activities of Daily Living Scale.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Cases screened for amyloid brain pathology in the NHO Niigata National Hospital for the treatment of Lecanemab, an approved drug.
• Exclude criteria: Patients who fall outside the indications for the approved drug Lecanemab. Patients who fall under the contraindications for the administration of the approved drug Lecanemab.

Related Information

• Primary Sponsor: Nakajima Takashi