RecruitingNot a traditional drug phaseobservationalRules rewrite

An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease

The goal of this watch-and-measure (no experimental treatment required) study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.

Official registry: https://clinicaltrials.gov/study/NCT07153848 · First Affiliated Hospital of Zhejiang University · enrollment listed as 400

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 400 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment

Primary outcome (registry wording): Number of participants with blood biomarkers

Who it is for (from inclusion criteria)

Ages 45 Years to 85 Years
(all of the following must be met simultaneously):
Mild Alzheimer's Disease (AD):
Age ≥ 45 years but ≤ 85 years;
Literacy level of elementary school and above (i.e., ≥3 years of education);
Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);
Clinical Dementia Rating Scale CDR-global = 1 point;
Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain

Who the registry excludes

(excluded if any of the following conditions were met):
Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;
Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;
Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;
Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);
Presence of contraindications to NMR such as metal implantation in the body;
Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;

Public study contact (from the registry)

Guoping Peng, PhD

13588150613

pgpfc@163.com

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

Sites listed on ClinicalTrials.gov

1 listed

The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (recruiting)

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FAQ about this NCT record

Is NCT07153848 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 NCT07153848?

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 NCT07153848?

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