Alzheimer Disease (AD)NCT07152418
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
An observational study of Alzheimer Disease (AD) and Alzheimer Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease (AD), Alzheimer Dementia, Mild Cognitive Impairment (MCI)
- What is being tested?
- Lecanemab 10 mg/kg and Conventional anti-dementia treatment group
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 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 Lecanemab and Conventional Anti-Dementia Treatment at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Who may be able to join
- Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. [Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology]
- Male or Female
- Between 50 and 85 years old (inclusive)
- Not currently participating in any other clinical trial or research study
- Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form
- Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion
Who cannot join
- Any contraindication to MRI
- History of seizure within the past 6 months or refractory epilepsy.
- Unstable or severe psychiatric illness within the past 6 months.
- History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count <50,000/μL or INR >1.5).
- Uncontrolled diabetes mellitus or hypertension.
- History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.
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- Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).
- Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.
- Breastfeeding individuals or women of childbearing potential not using highly effective contraception.
- History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.
- Being tested
- Lecanemab 10 mg/kg, Conventional anti-dementia treatment group
- Keywords
- Alzheimer Disease, lecanemab, Tau PET, Aβ PET
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecanemab 10 mg/kgBiological
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 is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.
Conventional anti-dementia treatment groupDrug
Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lecanemab treatment group | Lecanemab 10 mg/kg Receives: Biological: Lecanemab 10 mg/kg | |
| Conventional anti-dementia treatment | Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment. Receives: Drug: Conventional anti-dementia treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aβ-PET centiloid values
Statistical Comparison of Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores
Measured: Baseline, 18 months
Secondary outcomes (5)
Change from Baseline in the CDR at 18 Months
Assessment of the Statistical Difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: Baseline, 18 months
Change from Baseline in the MMSE at 18 Months
Assessment of the Statistically Significant Difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: Baseline, 18 months
Change from Baseline in the MoCA at 18 Months
Assessment of the Statistically Significant Difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: Baseline, 18 months
Change from Baseline in the NPI at 18 Months
Assessment of the Statistically Significant Difference in NPI Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: Baseline, 18 months
Blood AD molecular pathology
Assess statistically significant difference in score between Lecanemab treatment group and Conventional anti-dementia treatment using Plasma AD biomarkers (Aβ42, Aβ42/Aβ40, T-tau, P-tau181, P-tau231, P-tau217, NFL levels)
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 posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 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
- NCT07152418
- Sponsor's protocol ID
- 2025-0466
- Status last verified
- Jun 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
- ClinicalTrials.gov ID
- NCT07152418
- Acronym / sponsor ID
- 2025-0466
- Keywords
- Alzheimer Disease, lecanemab, Tau PET, Aβ PET
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Sep 2025 (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.
Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lecanemab treatment group | – | Biological: Lecanemab 10 mg/kgLecanemab 10 mg/kg |
| Conventional anti-dementia treatment | – | Drug: Conventional anti-dementia treatment groupEarly-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment. |
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 Lecanemab and Conventional Anti-Dementia Treatment at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. [Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology]
- Male or Female
- Between 50 and 85 years old (inclusive)
- Not currently participating in any other clinical trial or research study
- Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form
Key exclusion criteria (10 listed)
- Any contraindication to MRI
- History of seizure within the past 6 months or refractory epilepsy.
- Unstable or severe psychiatric illness within the past 6 months.
- History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count <50,000/μL or INR >1.5).
- Uncontrolled diabetes mellitus or hypertension.
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. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg. | Biological | Lecanemab treatment group |
| Conventional anti-dementia treatment groupConventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment. | Drug | Conventional anti-dementia treatment |
Primary outcome
Aβ-PET centiloid values
Time frame: Baseline, 18 months
Statistical Comparison of Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores
5 secondary outcomes
Change from Baseline in the CDR at 18 Months
Time frame: Baseline, 18 months
Change from Baseline in the MMSE at 18 Months
Time frame: Baseline, 18 months
Change from Baseline in the MoCA at 18 Months
Time frame: Baseline, 18 months
Change from Baseline in the NPI at 18 Months
Time frame: Baseline, 18 months
Blood AD molecular pathology
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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
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.
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 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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, M.D. (+86 139 5812 5492, 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 3 Sep 2025.