Mild cognitive impairment and mild dementia suspected to be due to Alzheimers disease
Conditions
Interventions
The protocol treatment in this study is defined as an amyloid PET scan using flutemetamol (18F) performed between the 7th and 8th donanemab administrations in the group initially positive for amyloid
Sponsors
Isohashi Kayako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with mild cognitive impairment or mild dementia suspected to be caused by Alzheimer's disease who underwent amyloid PET imaging using flutemetamol (18F) for the purpose of determining eligibility for anti-amyloid beta antibody therapy. (2) Patients for whom written consent for participation in this study is obtained from the patient themselves or from a surrogate decision-maker (in case of mild cognitive impairment).
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to any component of the flutemetamol (18F) formulation (2) Patients scheduled to use anti-amyloid beta antibody agents other than donanemab (3) Patients deemed unsuitable as study subjects by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging and clinical markers associated with amyloid PET negative conversion | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Temporal changes in amyloid PET negativity rate after donanemab initiation (2) Temporal changes in centiroid values and gray matter Standardized Uptake Value Ratio (SUVR) (3) Relationship between centroid values and changes in clinical markers | — |
Contacts
Public ContactKayako Isohashi
The University of Osaka Hospital
Outcome results
None listed