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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab Treatment Arm (Open-label) | Experimental | Subcutaneous Galcanezumab administration with an initial dose of 240 mg (single injection), followed by 120 mg every 4 weeks for a total of 6 doses (24-week treatment duration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CGRP Levels in Cerebrospinal Fluid and Plasma | Measurement of CGRP levels in cerebrospinal fluid and plasma. | Baseline; 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog) | baseline; 12 weeks; 36 weeks. | |
| Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog) | baseline; 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Tang, M.D., Ph.D. | Contact | 00861083199456 | tangyi@xwhosp.org | |
| Ouyang Chen, Ph.D. | Contact | 15652888562 | chenouyang@xwhosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Yi Tang | M.D., Ph.D. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
| C000605816 | erenumab |
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|
| Change from baseline on the Mini Mental state Examination (MMSE) score | baseline; 12 weeks; 24 weeks; 36 weeks. |
| Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | baseline; 12 weeks; 24 weeks; 36 weeks. |
| Change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC) | baseline; 12 weeks; 24 weeks; 36 weeks. |
| Change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL) | baseline; 12 weeks; 24 weeks; 36 weeks. |
| Change from baseline on the Neuropaychiatic Inventory (NPI) | baseline; 12 weeks; 24 weeks; 36 weeks |
| Change from baseline on the Hamilton depression scale (HAMD) | baseline; 12 weeks; 24 weeks; 36 weeks |
| Change from baseline in amplitude of Low-Frequency Fluctuations (ALFF) in resting-state functional MRI | baseline; 24 weeks. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |