Actively Recruiting
Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
Led by Xuanwu Hospital, Beijing · Updated on 2026-01-07
10
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 90 years at enrollment, regardless of gender
- Meets NIA-AA core clinical criteria for probable Alzheimer's disease
- Clinical Dementia Rating - Global Score between 1 and 2; Memory Box score 0.5 or higher
- Amyloid PET or cerebrospinal fluid biomarkers consistent with Alzheimer's disease pathology
- Mini-Mental State Examination score between 12 and 26
- Non-illiterate or has at least 4 to 6 years of formal education
- Stable psychiatric or cognitive-enhancing medication doses for at least 3 months prior to study, and stable non-AD medications for 4 weeks prior
- Has a reliable caregiver or legal guardian spending at least 8 hours per week with the participant
- Willing to participate, maintain existing treatments during the study, and provide signed informed consent
You will not qualify if you...
- Neuropsychiatric symptoms outside typical Alzheimer's disease spectrum
- History of transient ischemic attack, stroke, or seizure within the past 12 months
- Known allergy to gantenerumab or severe allergic reactions to monoclonal antibodies
- Cardiovascular or gastrointestinal diseases likely to worsen gastrointestinal adverse reactions
- Contraindications to MRI such as pacemaker, defibrillator, or metal implants
- MRI evidence of other dementia diagnoses or significant brain lesions unrelated to Alzheimer's disease
- Current participation in another clinical trial for Alzheimer's disease
- Unstable or inadequately controlled medical conditions compromising safety or assessments
- Other reasons determined by investigators precluding participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Y
Yi Tang, M.D., Ph.D.
CONTACT
O
Ouyang Chen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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