RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Lecanemab 10 mg/kg for Alzheimer s Disease

This research proposal outlines a multi-center, randomly assigned, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited.

Official registry: https://clinicaltrials.gov/study/NCT07604896 · First Affiliated Hospital of Wenzhou Medical University · enrollment listed as 200

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lecanemab 10 mg/kg, or Conventional anti-dementia treatment group. The registry lists allocation as randomized. This research proposal outlines a multi-center, randomly assigned, trial.

They plan to enroll about 200 people at Wenzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Interventions: Lecanemab 10 mg/kg, Conventional anti-dementia treatment group

Primary outcome (registry wording): Change in Aβ-PET centiloid values

Who it is for (from inclusion criteria)

Ages 50 Years to 90 Years
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

Who the registry excludes

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
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)
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 dummy treatment (placebo) treatment group

Public study contact (from the registry)

Zhen Wang, M.D.

+8613858868961

wangzhen@wzhospital.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (recruiting)

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FAQ about this NCT record

Is NCT07604896 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07604896?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07604896?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary