Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.

Eligibility criteria

Qualifiers

Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]

Male or female

50-85 years old

Not currently participating in other research studies

Disqualifiers

Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.

Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.

Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.

Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.

Trial design

Treatments tested in this trial

  • Lecanemab 10 mg/kg
  • Lecanemab 5-10mg/kg

Treatment groups

140 Participants
are divided into 2 treatment groups