Alzheimer s DiseasePhase 4NCT07604896
Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
A Phase 4 study testing Lecanemab 10 mg/kg and Conventional anti-dementia treatment group in people with Alzheimer s Disease and Alzheimer Dementia (AD), run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer s Disease, Alzheimer Dementia (AD), MCI-AD, Early Stage Alzheimer's Disease
- What is being tested?
- Lecanemab 10 mg/kg and Conventional anti-dementia treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Phase 4
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: 50 to 90 years old.
- No gender restrictions.
- Patients with MCI and mild AD.
- The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.
- Positive Amyloid protein confirmed by amyloid-PET or CSF.
- There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.
- Agree to participate in the research and sign the informed consent form.
Who cannot join
- Patients with cognitive impairment caused by reasons other than AD.
- There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.
- A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.
- Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.
- There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.
- There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
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- There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
- Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
- Surgical operations under general anesthesia are planned to be performed during the research period.
- Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.
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
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
First Affiliated Hospital of Wenzhou Medical University, +8613858868961, wyyy@wzhospital.cn
About this study
Official title: Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.
The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.
- Being tested
- Lecanemab 10 mg/kg, Conventional anti-dementia treatment group
- 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 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 | Experimental | Not described Receives: Drug: Lecanemab 10 mg/kg |
| Conventional anti-dementia treatment | Active comparator | Not described Receives: Drug: Conventional anti-dementia treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aβ-PET centiloid values
Change in Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores in 18 months
Measured: baseline, 12 month, 18 months
Secondary outcomes (6)
Change of retinal and cerbral imaging
Retinal and cerbral imaging Difference Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: baseline, 6 month, 12 month
Change of MoCA score
Assess the difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: baseline, 6 month, 12 month, 18 months
Change of MMSE score
Assess the difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: baseline, 6 month, 12 month, 18 months
Change of CDR score
Assess the difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Measured: baseline, 6 month, 12 month, 18 months
Change of structural MRI
3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
Measured: baseline, 6 month, 12 month, 18 month
Change of functional MRI
Blood oxygenation level dependent (BOLD) imaging
Measured: baseline, 6 month, 12 month, 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604896
- Sponsor's protocol ID
- KY2025-355
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No