Alzheimer Disease (AD)NCT07505095
Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice
An observational study of Alzheimer Disease (AD) and Alzheimer Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease (AD), Alzheimer Dementia, MCI-AD, Early Stage Alzheimer's Disease
- What is being tested?
- Lecanemab 10 mg/kg and Lecanemab 5-10mg/kg
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Jan 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included early AD patients treated with Standard-Dose Lecanemab (10mg/kg) and Low-Dose Lecanemab (5-10mg/kg) at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Who may be able to join
- Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]
- Male or female
- 50-85 years old
- Not currently participating in other research studies
- Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
- Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study
Who cannot join
- Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.
- Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.
- Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.
- Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.
- Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.
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
Human Subject Research Ethics Committee, 2ndAffiliated Hospital, School of Medicine, Zhejiang University,
Hangzhou, Zhejiang
About this study
This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.
- Being tested
- Lecanemab 10 mg/kg, Lecanemab 5-10mg/kg
- Keywords
- Alzheimer's Disease, lecanemab, different doses
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecanemab 10 mg/kgDrug
Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL.
Lecanemab 5-10mg/kgDrug
Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting
| Study group | Role | What they receive |
|---|---|---|
| Standard-Dose Treatment Group | lecanemab 10mg/kg Receives: Drug: Lecanemab 10 mg/kg | |
| Low-Dose Treatment Group | lecanemab 5-10mg/kg Receives: Drug: Lecanemab 5-10mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aβ-PET centiloid values
Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores
Measured: Baseline, 18 months
Secondary outcomes (4)
Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months
Assessment of the Statistical Difference in CDR Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Measured: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months
Assessment of the Statistically Significant Difference in MMSE Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Measured: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months
Assessment of the Statistically Significant Difference in MoCA Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Measured: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months
Assessment of the Statistically Significant Difference in NPI Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505095
- Sponsor's protocol ID
- 2025-1393
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice
- ClinicalTrials.gov ID
- NCT07505095
- Acronym / sponsor ID
- 2025-1393
- Keywords
- Alzheimer's Disease, lecanemab, different doses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 1 Apr 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 study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-Dose Treatment Group | – | Drug: Lecanemab 10 mg/kglecanemab 10mg/kg |
| Low-Dose Treatment Group | – | Drug: Lecanemab 5-10mg/kglecanemab 5-10mg/kg |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included early AD patients treated with Standard-Dose Lecanemab (10mg/kg) and Low-Dose Lecanemab (5-10mg/kg) at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]
- Male or female
- 50-85 years old
- Not currently participating in other research studies
- Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
Key exclusion criteria (5 listed)
- Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.
- Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.
- Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.
- Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.
- Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.
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 |
|---|---|---|
| Lecanemab 10 mg/kgLecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. | Drug | Standard-Dose Treatment Group |
| Lecanemab 5-10mg/kgLecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting | Drug | Low-Dose Treatment Group |
Primary outcome
Aβ-PET centiloid values
Time frame: Baseline, 18 months
Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores
4 secondary outcomes
Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months
Time frame: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months
Time frame: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months
Time frame: Baseline, 6 months, 12 months, 18 months
Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months
Time frame: Baseline, 6 months, 12 months, 18 months
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 1 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD) and Alzheimer Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Apr 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.
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 Jiong Zhou (13958125492, ze-zj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aβ-PET centiloid values (time frame: Baseline, 18 months). 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 1 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.