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NCT Number: NCT07505095

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

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.

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Key information

Conditions

Alzheimer Disease (AD) Alzheimer Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia MCI-AD, Early Stage Alzheimer's Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Aβ-PET centiloid values

    Time frame: Baseline, 18 months

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong Zhou

CONTACT

[email protected]

13958125492

Yaping Yan

CONTACT

[email protected]

+86 151 6831 2676

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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