Galcanezumab for amyloid-confirmed mild-to-moderate Alzheimer's disease

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

This trial will try injectable Galcanezumab in people aged 50–90 with amyloid-confirmed mild-to-moderate Alzheimer's disease to see if it improves symptoms or slows decline.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Drugs / interventions: gantenerumab, Galcanezumab
• Locations: 1 site (Beijing)
• Trial ID: NCT07323927 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label early phase 1 study at Xuanwu Hospital in Beijing gives subcutaneous Galcanezumab with a 240 mg loading dose followed by 120 mg every four weeks for six total doses over 24 weeks. Participants have biomarker-confirmed probable Alzheimer's disease and undergo clinical and safety assessments at baseline, week 12, week 24, and a follow-up visit at week 36. Cognitive testing, clinical ratings, and safety monitoring are used to track changes in symptoms and adverse events over time. The trial requires a reliable caregiver and stable concomitant medications where applicable.

Who should consider this trial

Good fit: Ideal candidates are people aged 50–90 with probable Alzheimer's disease confirmed by amyloid PET or CSF, MMSE 12–26, CDR global 1–2, and a reliable caregiver able to support study visits.

Not a fit: Patients without amyloid-positive biomarkers, with severe dementia, unstable medical or psychiatric conditions, or who cannot travel to the Beijing site are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, Galcanezumab could slow cognitive decline or improve daily functioning in people with amyloid-confirmed mild-to-moderate Alzheimer's disease.

How similar studies have performed: Using Galcanezumab for Alzheimer's is a novel approach with little prior clinical evidence, though other monoclonal antibodies targeting Alzheimer's pathology have produced mixed results.

Eligibility criteria

Inclusion Criteria:

1. Age between 50 and 90 years at enrollment, regardless of gender;
2. Meeting the NIA-AA core clinical criteria for probable Alzheimer's disease;
3. Clinical Dementia Rating - Global Score (CDR-GS) between ≥1 and ≤2; Clinical Dementia Rating - Memory Box (CDR-Memory box) ≥0.5;
4. Amyloid PET or cerebrospinal fluid (CSF) biomarkers consistent with AD pathology;
5. Mini-Mental State Examination (MMSE) score between ≥12 and ≤26;
6. Non-illiterate or with at least 4 to 6 years of formal education;
7. If currently taking psychiatric or cognitive-enhancing medications, the dosage must have been stable for at least 3 months prior to the study and remain unchanged during the study. Unless otherwise specified, all permitted concomitant medications (non-AD related) must have been stable for at least 4 weeks prior to baseline;
8. Availability of a reliable caregiver or legal guardian able to support the participant throughout the study, defined as spending at least 8 hours per week with the participant;
9. Willingness to participate in the clinical trial, maintain existing interventions during the study period, and provision of signed informed consent.

Exclusion Criteria:

1. Presence of neuropsychiatric symptoms outside the typical spectrum of Alzheimer's disease;
2. History of transient ischemic attack (TIA), stroke, or seizure within the past 12 months;
3. Known allergy to gantenerumab or its excipients, or severe allergic reactions to monoclonal antibodies;
4. Cardiovascular or gastrointestinal diseases including severe arrhythmias, uncontrolled hypertension (systolic \>180 mmHg or diastolic \>110 mmHg), or active peptic ulcer disease, inflammatory bowel disease, or other conditions likely to exacerbate gastrointestinal adverse reactions;
5. MRI contraindications such as cardiac pacemaker/defibrillator or ferromagnetic metal implants;
6. MRI evidence of other clinically significant lesions suggesting dementia diagnoses other than AD;
7. MRI findings of other important pathologies, including but not limited to: single hemorrhagic lesions \>10 mm in diameter; evidence of vasogenic edema; brain contusions, softening, aneurysms, vascular malformations, or infectious lesions; strokes involving major vascular territories; severe small vessel or white matter disease; space-occupying lesions; or brain tumors (meningiomas or arachnoid cysts with a maximum diameter \<1 cm may be allowed);
8. Current participation in another clinical trial targeting AD improvement;
9. Any unstable or inadequately controlled medical condition, or other situations deemed by investigators to compromise participant safety or study assessments;
10. Other investigator-determined reasons precluding participant inclusion.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yi Tang, M.D., Ph.D.

Conditions: Alzheimer Disease, Alzheimer disease, Galcanezumab