Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease

December 23, 2025 updated by: Xuanwu Hospital, Beijing

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

This single-arm, open-label clinical study systematically evaluates the efficacy and safety of Galcanezumab in patients with mild-to-moderate Alzheimer's disease (AD). Eligible participants who provided written informed consent were screened and enrolled to receive Galcanezumab treatment. The therapeutic regimen involved subcutaneous administration of Galcanezumab with an initial 240 mg loading dose followed by 120 mg maintenance doses every four weeks for six total administrations over a 24-week treatment period. All study procedures were conducted at the Advanced Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University. Comprehensive data collection and clinical assessments were performed at baseline (pre-treatment), week 12 (Visit 3), week 24 (Visit 4), and week 36 (Visit 5, 12 weeks after the final dose) to evaluate treatment outcomes and safety profiles. The study design incorporates standardized clinical trial methodology while maintaining the flexibility required for exploratory therapeutic evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Galcanezumab Treatment Arm (Open-label)
Subcutaneous Galcanezumab administration with an initial dose of 240 mg (single injection), followed by 120 mg every 4 weeks for a total of 6 doses (24-week treatment duration).
Drug: Galcanezumab
Subcutaneous injection; monotherapy (administered at the designated study site: Advanced Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University); initial dose: 240 mg (single administration) followed by 120 mg every 4 weeks for 6 total doses
Other Names:
  • Emgality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CGRP Levels in Cerebrospinal Fluid and Plasma
Time Frame: Baseline; 24 weeks.
Measurement of CGRP levels in cerebrospinal fluid and plasma.
Baseline; 24 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time Frame: baseline; 12 weeks; 36 weeks.
baseline; 12 weeks; 36 weeks.
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time Frame: baseline; 24 weeks.
baseline; 24 weeks.
Change from baseline on the Mini Mental state Examination (MMSE) score
Time Frame: baseline; 12 weeks; 24 weeks; 36 weeks.
baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time Frame: baseline; 12 weeks; 24 weeks; 36 weeks.
baseline; 12 weeks; 24 weeks; 36 weeks.
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.
baseline; 12 weeks; 24 weeks; 36 weeks.
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.
baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Neuropaychiatic Inventory (NPI)
Time Frame: baseline; 12 weeks; 24 weeks; 36 weeks
baseline; 12 weeks; 24 weeks; 36 weeks
Change from baseline on the Hamilton depression scale (HAMD)
Time Frame: baseline; 12 weeks; 24 weeks; 36 weeks
baseline; 12 weeks; 24 weeks; 36 weeks
Change from baseline in amplitude of Low-Frequency Fluctuations (ALFF) in resting-state functional MRI
Time Frame: baseline; 24 weeks.
baseline; 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yi Tang, M.D., Ph.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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