RecruitingEarly Phase 1NCT07323927

Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease

An Investigator Initiated Trial Evaluating the Therapeutic Efficacy of Galcanezumab in Patients With Alzheimer's Disease


Sponsor

Xuanwu Hospital, Beijing

Enrollment

10 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing galcanezumab — a drug typically used to prevent migraines — to see if it has any effect on slowing the progression of Alzheimer's disease. Some research suggests this drug may protect nerve cells in the brain. **You may be eligible if...** - You are 50–90 years old - You have been diagnosed with probable Alzheimer's disease (moderate severity) - Brain imaging or spinal fluid tests confirm the presence of Alzheimer's-related protein changes (amyloid) - Your memory and thinking scores fall within the moderate range on standard tests (MMSE 12–26, CDR 1–2) - You have a reliable caregiver who spends at least 8 hours a week with you - Any medications for your brain or mood have been at a stable dose for at least 3 months **You may NOT be eligible if...** - You have psychiatric symptoms that are not typical of Alzheimer's (hallucinations, etc.) - You have had a stroke, TIA, or seizure in the past 12 months - You have uncontrolled high blood pressure or serious heart or gastrointestinal problems - You cannot have an MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGalcanezumab

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


Locations(1)

Xuanwu Hospital, Capital Medical University

Beijing, China

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Visit

NCT07323927


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