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RecruitingPhase EARLY_1

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

Asset

Galcanezumab

Listed sites

1

Recruiting sites

1

Enrollment

10

estimated

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseAmyloid biomarker required (PET/CSF)MMSE 12-26Study partner/caregiver requiredMRI 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

Org study ID2025162
NCT IDNCT07323927

Timeline

Milestones

Study start2025-08-01actual
Study first posted2026-01-07actual
Last update posted2026-01-07actual
Primary completion2027-01-01estimated
Study completion2027-03-31estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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
Behavior / neuropsychiatric
2
Function / daily living
1
Neuroimaging
1
Fluid / digital biomarkers
1
Other clinical outcomes
1

Global cognition

4 endpoints
Secondary/protocol endpoint

Change 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Secondary/protocol endpoint

Change from baseline on the Neuropaychiatic Inventory (NPI)

Time frame:baseline; 12 weeks; 24 weeks; 36 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the Hamilton depression scale (HAMD)

Time frame:baseline; 12 weeks; 24 weeks; 36 weeks

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change 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 endpoint
Primary/protocol endpoint

CGRP Levels in Cerebrospinal Fluid and Plasma

Time frame:Baseline; 24 weeks.

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change 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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.