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Not yet recruiting NCT07505095

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

— Observational Alzheimer Disease (AD) Alzheimer Dementia MCI-AD, Early Stage Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lecanemab 10 mg/kg, Lecanemab 5-10mg/kg.
Who it may be relevant to
Registry conditions: Alzheimer Disease (AD), Alzheimer Dementia, MCI-AD, Early Stage Alzheimer's Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Lecanemab 10 mg/kg
    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.
  • Drug Lecanemab 5-10mg/kg
    Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting

Primary outcome measures

  • Aβ-PET centiloid values [Time frame: Baseline, 18 months]
Secondary outcome measures (4)
  • Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months [Time frame: Baseline, 6 months, 12 months, 18 months]
  • Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months [Time frame: Baseline, 6 months, 12 months, 18 months]
  • Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months [Time frame: Baseline, 6 months, 12 months, 18 months]
  • Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months [Time frame: Baseline, 6 months, 12 months, 18 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
  • Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study

Exclusion criteria

  • 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.
  • Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Human Subject Research Ethics Committee, 2ndAffiliated Hospital, School of Medicine, Zheji — Hangzhou

Identifiers

NCT: NCT07505095 · 2025-1393

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗