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Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
An Investigator Initiated Trial Evaluating the Therapeutic Efficacy of Galcanezumab in Patients With Alzheimer's Disease
Lead sponsor
Asset
Galcanezumab
Listed sites
1
Recruiting sites
1
Enrollment
10
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•MMSE 12-26•Study partner/caregiver required•MRI contraindications excluded
Primary endpoint
•CGRP Levels in Cerebrospinal Fluid and Plasma
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
4 endpointsChange from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame:baseline; 12 weeks; 36 weeks.
ADAS-Cog
change from baseline, improvement
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame:baseline; 24 weeks.
ADAS-Cog
change from baseline, improvement
Change from baseline on the Mini Mental state Examination (MMSE) score
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks.
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks.
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Function / daily living
1 endpointChange from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks.
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
Behavior / neuropsychiatric
2 endpointsChange from baseline on the Neuropaychiatic Inventory (NPI)
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Change from baseline on the Hamilton depression scale (HAMD)
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks
change from baseline, improvement
Neuroimaging
1 endpointChange from baseline in amplitude of Low-Frequency Fluctuations (ALFF) in resting-state functional MRI
Time frame:baseline; 24 weeks.
change from baseline, improvement
Fluid / digital biomarkers
1 endpointCGRP Levels in Cerebrospinal Fluid and Plasma
Time frame:Baseline; 24 weeks.
descriptive
Other clinical outcomes
1 endpointChange from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Time frame:baseline; 12 weeks; 24 weeks; 36 weeks.
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.