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

N/ANot Yet RecruitingNCT07505095

Second Affiliated Hospital, School of Medicine, Zhejiang University140 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

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

Interventions

Lecanemab 10 mg/kgDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Aβ-PET centiloid values

Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores

Time frame: Baseline, 18 months

Secondary Outcomes

Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months

Assessment of the Statistical Difference in CDR Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group

Time frame: Baseline, 6 months, 12 months, 18 months

Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months

Assessment of the Statistically Significant Difference in MMSE Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group

Time frame: Baseline, 6 months, 12 months, 18 months

Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months

Assessment of the Statistically Significant Difference in MoCA Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group

Time frame: Baseline, 6 months, 12 months, 18 months

Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months

Assessment of the Statistically Significant Difference in NPI Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group

Time frame: Baseline, 6 months, 12 months, 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts