Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease

Más betegség

• 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);
• Any unstable or inadequately controlled medical condition, or other situations deemed by investigators to compromise participant safety or study assessments;

Egyéb

• Current participation in another clinical trial targeting AD improvement;
• Other investigator-determined reasons precluding participant inclusion.

• 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.