drugset / Trial / NCT07323927

Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease

NCT07323927

Phase 0 Recruiting 10 enrolled Xuanwu Hospital, Beijing
NaSingle-groupOpen-labelTreatment

Summary

This single-arm, open-label clinical study systematically evaluates the efficacy and safety of Galcanezumab in patients with mild-to-moderate Alzheimer's disease (AD). Eligible participants who provided written informed consent were screened and enrolled to receive Galcanezumab treatment. The therapeutic regimen involved subcutaneous administration of Galcanezumab with an initial 240 mg loading dose followed by 120 mg maintenance doses every four weeks for six total administrations over a 24-week treatment period. All study procedures were conducted at the Advanced Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University. Comprehensive data collection and clinical assessments were performed at baseline (pre-treatment), week 12 (Visit 3), week 24 (Visit 4), and week 36 (Visit 5, 12 weeks after the final dose) to evaluate treatment outcomes and safety profiles. The study design incorporates standardized clinical trial methodology while maintaining the flexibility required for exploratory therapeutic evaluation.

Timeline

Start
2025-08-01
Primary completion
2027-01-01
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Galcanezumab Monoclonal antibody 120 mg Subcutaneous

Indications