MCI,mildAD AD
Conditions
Interventions
Off-label use of PET tracers
Use an unapproved PET tracer
Sponsors
Takashi Kato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who have given written consent 2) Those who are in good general condition and willing to cooperate with the examination 3) Those who were considered for use of amyloid antibody drugs at a hospital outpatient clinic, etc. 4) Aged 40 to 90 years at the time of consent
Exclusion criteria
Exclusion criteria: 1) Clinical history of cerebrovascular diseases,brain tumors, or other neurological disorders thatmay cause cognitive impairment or dementia. However, cerebrovascular dementia is not excluded.Those with a history of brain tumors, head trauma, or neurodegenerative diseases other than dementia that may affect cognitive function. However, those suspected of having cerebrovascular dementia will not be excluded. 2) Deformity or disorders of the spine or hip joint. In contraindication to having MRI scan. 3) Anyone with an electrically, magnetically or mechanically operated implant, such as a cardiac pacemaker, an internal nerve stimulator, a bone growth stimulator, an internal automatic defibrillator, or a cochlear implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predict the positive or negative outcome of amyloid PET by visual reading before and after the start of treatment based on blood biomarker values. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Dividing patients into a lecanemab treatment group and a donanemab treatment group, can the positive or negative judgment by visual reading of amyloid-PET before and after the start of treatment in each group be predicted from blood biomarker values (individual values or combinations of p-tau217, amyloid-beta42, amyloid-beta40)? 2) The optimal values of blood biomarker values (individual values or combinations of p-tau217, amyloid-beta42, and amyloid-beta40 (amyloid-beta42/amyloid-beta40, p-tau217/amyloid-beta42, p-tau217/amyloid-beta42/amyloid-beta40)) collected at the same time for a positive or negative amyloid PET result after the start of treatment will be determined using ROC analysis, and the diagnostic performance will be compared with the diagnostic performance obtained in the primary evaluation. In addition, the optimal values of the blood biomarkers will be compared with the cutoff values before treatment determined in other studies. 3) In amyloid antibody drug treatment, can the values and changes in brain amyloid accumulation measured by amyloidPET before and after the start of treatment be predicted from blood biomarker values, etc.? 4) In amyloid antibody drug treatment, can the degree of change in cognitive function (MMSE, etc.) be predicted by combining blood biomarker values, amyloid PET and tau PET values, age, etc.? 5) In amyloid antibody drug treatment, are neurophysiological parameters measured by MEG or fMRI associated with the amount of amyloid accumulation in the brain, the amount of tau accumulation, or blood biomarker values? (Exploratory study) | — |
Contacts
Public ContactMaeda Mayumi
National Center for Geriatrics and Gerontology
Outcome results
None listed