Alzheimer DiseaseEarly Phase 1NCT07323927
Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
A Early Phase 1 study testing Galcanezumab in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Galcanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Yi Tang, M.D., Ph.D., 00861083199456, tangyixw@vip.163.com
About this study
Official title: 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.
- Conditions
- Alzheimer Disease
- Being tested
- Galcanezumab
- Keywords
- Alzheimer disease, Galcanezumab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalcanezumabDrug
Also called Emgality
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
| Study group | Role | What they receive |
|---|---|---|
| Galcanezumab Treatment Arm (Open-label) | Experimental | 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). Receives: Drug: Galcanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGRP Levels in Cerebrospinal Fluid and Plasma
Measurement of CGRP levels in cerebrospinal fluid and plasma.
Measured: Baseline; 24 weeks.
Secondary outcomes (9)
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: baseline; 12 weeks; 36 weeks.
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: baseline; 24 weeks.
Change from baseline on the Mini Mental state Examination (MMSE) score
Measured: baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Measured: 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)
Measured: baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Measured: baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Neuropaychiatic Inventory (NPI)
Measured: baseline; 12 weeks; 24 weeks; 36 weeks
Change from baseline on the Hamilton depression scale (HAMD)
Measured: baseline; 12 weeks; 24 weeks; 36 weeks
Change from baseline in amplitude of Low-Frequency Fluctuations (ALFF) in resting-state functional MRI
Measured: baseline; 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, Study chair, M.D., Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323927
- Sponsor's protocol ID
- 2025162
- Status last verified
- Mar 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Trial Evaluating the Therapeutic Efficacy of Galcanezumab in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07323927
- Acronym / sponsor ID
- 2025162
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Galcanezumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galcanezumab Treatment Arm (Open-label) | Experimental | Drug: GalcanezumabSubcutaneous 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). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalcanezumabAlso: EmgalitySubcutaneous 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 | Drug | Galcanezumab Treatment Arm (Open-label) |
Primary outcome
CGRP Levels in Cerebrospinal Fluid and Plasma
Time frame: Baseline; 24 weeks.
Measurement of CGRP levels in cerebrospinal fluid and plasma.
9 secondary outcomes
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: baseline; 12 weeks; 36 weeks.
Change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: baseline; 24 weeks.
Change from baseline on the Mini Mental state Examination (MMSE) score
Time frame: 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.
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 on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Time frame: baseline; 12 weeks; 24 weeks; 36 weeks.
Change from baseline on the Neuropaychiatic Inventory (NPI)
Time frame: 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
Change from baseline in amplitude of Low-Frequency Fluctuations (ALFF) in resting-state functional MRI
Time frame: baseline; 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Tang study chair
M.D., Ph.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Galcanezumab in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, M.D., Ph.D. (00861083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGRP Levels in Cerebrospinal Fluid and Plasma (time frame: Baseline; 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.