Skip to content

Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study

Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study - ATT decision-making study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060413
Enrollment
50
Registered
2026-01-20
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Alzheimer&#39

Interventions

None listed

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients clinically diagnosed with probable Alzheimer's disease dementia or MCI due to Alzheimer's disease at participating institutions between the ethics approval date and March 31, 2027. Patients who underwent amyloid PET and were confirmed positive. Patients for whom intravenous treatment with lecanemab or donanemab has been determined to be appropriate by the attending physician. Patients who have provided written informed consent, either directly or via a legally authorized representative. Age between 50 and 90 years.

Exclusion criteria

Exclusion criteria: - Patients whose amyloid PET result was negative at the baseline evaluation - Patients diagnosed with mild cognitive impairment or dementia due to other neurodegenerative diseases or medical conditions - Patients deemed unsuitable for participation in this study by the attending physician

Design outcomes

Primary

MeasureTime frame
MacCATT total score and its association with clinical variables (cognitive function, neuropsychiatric symptoms, psychological loneliness, ADL, MRI findings, amyloid PET findings).

Secondary

MeasureTime frame
Associations between MacCATT subscale scores and amyloid PET parameters (SUVR, composite SUVR, centiloid, asymmetry index). Longitudinal changes in treatment decision-making capacity at 6, 12, and 18 months and their associations with clinical variables.

Countries

Japan

Contacts

Public ContactKoji Kasanuki

St. Marianna Universitiy School of Medicine Department of Neuropsychiatry

koji.kasanuki@marianna-u.ac.jp0449778111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026