NCT07323927 · Early Phase 1 · RECRUITING
Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
This trial is testing galcanezumab, a drug best known for preventing migraines, as a possible treatment for mild-to-moderate Alzheimer's disease. Participants receive injections under the skin over 24 weeks, and researchers are tracking whether it helps and whether it is safe. This is an Early Phase 1 study, meaning it is very early-stage, exploratory, and not yet close to being proven or approved for Alzheimer's.
You may qualify if
- Age between 50 and 90 years at enrollment, regardless of gender;
- Meeting the NIA-AA core clinical criteria for probable Alzheimer's disease;
- Clinical Dementia Rating - Global Score (CDR-GS) between ≥1 and ≤2; Clinical Dementia Rating - Memory Box (CDR-Memory box) ≥0.5;
- Amyloid PET or cerebrospinal fluid (CSF) biomarkers consistent with AD pathology;
- Mini-Mental State Examination (MMSE) score between ≥12 and ≤26;
- Non-illiterate or with at least 4 to 6 years of formal education;
- 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;
- 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;
- Willingness to participate in the clinical trial, maintain existing interventions during the study period, and provision of signed informed consent.
You're excluded if
- Presence of neuropsychiatric symptoms outside the typical spectrum of Alzheimer's disease;
- History of transient ischemic attack (TIA), stroke, or seizure within the past 12 months;
- Known allergy to gantenerumab or its excipients, or severe allergic reactions to monoclonal antibodies;
- 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;
- MRI contraindications such as cardiac pacemaker/defibrillator or ferromagnetic metal implants;
- MRI evidence of other clinically significant lesions suggesting dementia diagnoses other than AD;
- 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);
- Current participation in another clinical trial targeting AD improvement;
- Any unstable or inadequately controlled medical condition, or other situations deemed by investigators to compromise participant safety or study assessments;
- Other investigator-determined reasons precluding participant inclusion.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-07