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

Phase 4
Active, not recruiting
Conditions
Alzheimer's Disease(AD)
Interventions
Drug: Administer Leqemi 10 mg/kg, every two weeks.
Registration Number
NCT07034222
Lead Sponsor
Ruijin Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Lecanemab treatment groupAdminister Leqemi 10 mg/kg, every two weeks.receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes.
Primary Outcome Measures
NameTimeMethod
Change in Amyloid Burden as Assessed by Centiloid ScaleBaseline, 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

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

Secondary Outcome Measures
NameTimeMethod
Incidence of treatment-emergent adverse events (TEAEs)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

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

Change in Cognitive Function as Assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)Baseline, 3 months, 6 months, 12 months

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

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

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

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

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

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

🇨🇳

Shanghai, Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China

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