RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Lecanemab treatment group for Alzheimer's Disease

Alzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families.

Official registry: https://clinicaltrials.gov/study/NCT06871839 · Cuibai Wei，Clinical Professor · enrollment listed as 120

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

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

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 120 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

Interventions: Lecanemab treatment group, Conventional anti-dementia treatment group

Primary outcome (registry wording): Resting-state fMRI brain network metrics (Independent Component Analysis)

Who it is for (from inclusion criteria)

Ages 50 Years to 90 Years
Age between 50 and 90 years
Male or female patients
Patients with MCI and mild AD
MMSE score ≥20, CDR overall score of 0.5 or 1
Amyloid-positive confirmed by Amyloid-PET or CSF
Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial

Who the registry excludes

Patients with cognitive impairment due to reasons other than AD
A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening
Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study
A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment
Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning)
A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening
Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the dummy treatment (placebo) treatment group

Public study contact (from the registry)

Cui bai Wei

83198319

weicb@xwhosp.org

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

Sites listed on ClinicalTrials.gov

1 listed

Capital Medical University Xuanwu Hospital — Beijing, China (recruiting)

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FAQ about this NCT record

Is NCT06871839 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 NCT06871839?

Not a traditional drug phase. 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 NCT06871839?

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

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Not a traditional drug phase: testing Lecanemab treatment group for Alzheimer&#39;s Disease