Skip to content

Real-world study of efficacy, disease trajectory, and safety of lecanemab in patients with Alzheimer’s disease

Real-world study of efficacy, disease trajectory, and safety of lecanemab in patients with Alzheimer’s disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098314
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-03-02
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Alzheimers disease

Interventions

Observation group:None

Sponsors

Shandong Provincial Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age= 3 months or assessed by a specialist); Clinical decision-making is made based on the patient’s ability to safely participate in the treatment regimen; 7. Mental disease protocol: stable mental status (as assessed by the specialist); Clinical decision-making based on the patient’s ability to safely participate in the treatment regimen; 8. The subject is allowed to use cholinesterase inhibitors and memantine; 9. The subject is able to complete the cognitive ability test specified in the protocol; 10. The subject should be a stable and reliable caregiver, and the caregiver will help the subject participate in the whole study process. The caregiver must accompany the subject for study visits and must have sufficient interaction and communication with the subject to provide valuable information for study-related questionnaires and scale assessments; 11. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Bleeding disorders or taking anticoagulants. 2. Rule out acute or subacute bleeding, major bleeding, more than 4 microbleeds, cortical infarction (> 1.5 cm), more than 1 infarct (> 1.5 cm), surface siderosis, diffuse white matter disease. 3. Exclude non-Alzheimer's disease neurological degenerative disease. 4. Rule out angina, myocardial infarction, congestive heart failure. 5. Rule out other clinically significant systemic diseases, uncontrolled diabetes, uncontrolled hypertension,unstable malignant tumor, hepatitis or liver dysfunction, HIV infection. 6, exclusion of unstable mental illness within the previous 6 months; substance addiction or drug-induced mental disorder. 7, unwillingness to sign the informed consent form. 8, pregnant or lactating women; 9. unable to cooperate with the completion of follow-up; 10. Any other diseases or conditions that are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Cognitive activity scale score;

Secondary

MeasureTime frame
Physical examination;

Countries

China

Contacts

Public ContactHou Tingting

Shandong Provincial Hospital of Shandong First Medical University

httl-001@163.com+86 156 6584 6267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026