Mild Alzheimers disease (CDR=0.5 and 1.0)
Conditions
Interventions
None listed
Sponsors
Nakajima Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients screened for amyloid pathology in preparation for treatment with the approved drugs lecanemab or donanemab
Exclusion criteria
Exclusion criteria: Patients who fall outside the indications for the approved anti-amyloid drugs Lecanemab and Donanemab. Patients who have contraindications to the administration of the approved anti-amyloid drugs Lecanemab and Donanemab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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-amyloid42 pg/ml, beta-amyloid40 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. | — |
Contacts
Public ContactTakashi Nakajima
National Hospital Organization Niigata National Hospital
Outcome results
None listed