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NCT Number: NCT07034222

12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease

This is a 12-month, single-arm, real-world study designed to evaluate the efficacy and safety of lecanemab (10 mg/kg administered every two weeks) in patients with early Alzheimer's disease, including mild cognitive impairment (MCI) due to AD or mild AD dementia, confirmed by amyloid-positive Aβ-PET scans. The study will enroll 80 participants, with both retrospective and prospective data collection.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer's Disease(AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

The study enrolled participants with mild cognitive impairment due to AD or mild AD. All participants received biweekly intravenous infusions of lecanemab at a dose of 10 mg/kg. Safety data was collected, particularly for amyloid-related imaging abnormalities (ARIA). Effectiveness evaluations included cognitive tests, plasma biomarker analysis, and advanced neuroimaging.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meets the NIA-AA 2011 diagnostic criteria for:

Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD) or Mild Alzheimer's Disease Dementia.

-Confirmed Aβ pathology by: Aβ-PET scan or CSF Aβ42/Aβ40 ratio (results within 6 months prior to screening).

-Cognitive scales (within 3 months): Clinical Dementia Rating (CDR) global score 0.5-1 and/or Mini-Mental State Examination (MMSE) score 20-30.

  • APOE genotype results available.
  • MRI/SWI eligibility:
  • No exclusionary findings (see Exclusion Criteria for details).
  • Laboratory tests within normal ranges or deemed non-clinically significant by the investigator:

Routine tests: Liver/kidney function, CBC, urinalysis, fecal occult blood. Thyroid function: Free T3, free T4, TSH. Vitamin B12 (and methylmalonic acid [MMA], if available). Coagulation panel: PT/INR, aPTT (required). Negative for syphilis, HIV, or other infections that may affect cognition.

Exclusion criteria

  • MRI/SWI exclusionary findings: 4 microhemorrhages (maximum diameter ≤10 mm). Any macrohemorrhage (>10 mm in diameter). Cortical superficial siderosis. Vasogenic edema. Evidence of brain contusion, encephalomalacia, vascular malformations, or infectious lesions.

Multiple lacunar infarcts/strokes in major vascular territories, severe small vessel disease, or severe white matter lesions (Fazekas grade ≥3).

Space-occupying lesions or brain tumors (except asymptomatic meningiomas/arachnoid cysts <1 cm).

Treatment and study plan

Administer Leqemi 10 mg/kg, every two weeks.

Drug

Receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes. The infusion system must use a 0.2-μM terminal line filter for administration.

Primary outcomes

  1. Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR)

    Time frame: Baseline, 6 months, 12 months

    Measurement:

    Unit of Measure: SUVR (unitless ratio) Reference Region: Cerebellar gray matter Range: Typically 1.0-3.0 in amyloid-positive subjects Direction: Lower values indicate greater amyloid clearance

  2. Change in Amyloid Burden as Assessed by Centiloid Scale

    Time frame: Baseline, 6 months, 12 months

    Measurement:

    Unit of Measure: Centiloids (CL)

    Scale Range:

    0 CL: Young healthy controls 100 CL: Typical Alzheimer's dementia threshold Direction: Lower values indicate greater amyloid clearance

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 0-12 months (continuous monitoring)

    Safety evaluation including:

    All adverse events (AEs) Hematological and biochemical laboratory abnormalities Vital sign changes ECG abnormalities ARIA (amyloid-related imaging abnormalities) monitoring via brain MRI with specific protocols for ARIA-H (hemorrhage) and ARIA-E (edema) management

  2. Change in Cognitive Function as Assessed by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Scale Details:

    Score Range: 0 (best) to 18 (worst) Boxes Assessed:Memory，Orientation，Judgment & Problem Solving，Community Affairs，Home & Hobbies，Personal Care Scoring: Each domain rated 0 (none) to 3 (severe) Higher Score Indicates: Worse cognitive/functional impairment

  3. Change in Cognitive Function as Assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Comprehensive neuropsychological test battery Scale range: 0 (best) to 90 (worst) Higher score indicates greater cognitive impairment

  4. Change in Cognitive Function as Assessed by Mini-Mental State Examination (MMSE)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Mini-Mental State Examination (MMSE) Scale range: 0 (worst) to 30 (best) Higher score indicates better cognitive function

  5. Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Scale Details:

    Total Score Range: 0 (best) to 144 (worst) Subscale Range (Frequency × Severity): 0-12 per domain Higher Score Indicates: Worse neuropsychiatric symptoms

    Domains Assessed:

    Delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, appetite/eating

  6. Change in Functional Abilities as Assessed by the Alzheimer's Disease Cooperative Study-Activities of Daily Living for Mild Cognitive Impairment (ADCS MCI-ADL)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Scale Details:

    Score Range: 0 (worst) to 53 (best) Higher Scores Indicate: Better daily functioning (less impairment)

    Assessed Domains:

    Basic ADLs (e.g., eating, dressing) Instrumental ADLs (e.g., shopping, managing finances)

  7. Change in Caregiver Burden as Assessed by the Zarit Burden Interview (ZBI)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Scale Details:

    Score Range: 0 (no burden) to 88 (severe burden) Higher Scores Indicate: Worse caregiver distress

    Interpretation:

    0-20: Little to no burden 21-40: Mild to moderate burden 41-60: Moderate to severe burden 61-88: Severe burden

Other outcomes

  1. Change in Plasma Aβ42/40 Ratio

    Time frame: Baseline, 3 months, 6 months, 12 months

    Technology: Single Molecule Array (Simoa™, Quanterix) digital immunoassay

  2. Change in Plasma Phosphorylated Tau (p-tau181)

    Time frame: Baseline, 6 months, 12 months

    Single Molecule Array (Simoa™, Quanterix) digital immunoassay

  3. Change in Plasma Neurofilament Light (NfL)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Single Molecule Array (Simoa™, Quanterix) digital immunoassay

  4. Change in Plasma Glial Fibrillary Acidic Protein (GFAP)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Single Molecule Array (Simoa™, Quanterix) digital immunoassay

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A 12-month Single-arm Real-world Study to Determine the Safety and Efficacy of Lecanemab in Patients With Early Alzheimer's Disease

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

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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