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

NCT07505095 | Not Yet Recruiting

• 1 other identifier: 2025-1393
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Alzheimer's Disease; lecanemab; different doses

Outcome Measures

Primary Outcomes (1)

• Aβ-PET centiloid values

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

  Baseline, 18 months

Secondary Outcomes (4)

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

  Baseline, 6 months, 12 months, 18 months

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

  Baseline, 6 months, 12 months, 18 months

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

  Baseline, 6 months, 12 months, 18 months

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

  Baseline, 6 months, 12 months, 18 months

Study Arms (2)

Standard-Dose Treatment Group

lecanemab 10mg/kg

Drug: Lecanemab 10 mg/kg

Low-Dose Treatment Group

lecanemab 5-10mg/kg

Drug: Lecanemab 5-10mg/kg

Interventions

Lecanemab 10 mg/kg DRUG

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.

Standard-Dose Treatment Group

Lecanemab 5-10mg/kg DRUG

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

Low-Dose Treatment Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included early AD patients treated with Standard-Dose Lecanemab (10mg/kg) and Low-Dose Lecanemab (5-10mg/kg) at the Second Affiliated Hospital of Zhejiang University School of Medicine.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Human Subject Research Ethics Committee, 2ndAffiliated Hospital, School of Medicine, Zhejiang University,

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jiong Zhou

CONTACT

13958125492; ze-zj@zju.edu.cn

Yaping Yan

CONTACT

+86 151 6831 2676; yanyaping@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)