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Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease

NCT07323927 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Galcanezumab

Subcutaneous injection; monotherapy (administered at the designated study site: Advanced Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University); initial dose: 240 mg (single administration) followed by 120 mg every 4 weeks for 6 total doses

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Yi Tang · M.D., Ph.D.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-01-01
Completion
2027-03-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07323927 on ClinicalTrials.gov