12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease
- 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
- 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.
- 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
Group Intervention Description Lecanemab treatment group Administer 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
Name Time Method Change in Amyloid Burden as Assessed by Centiloid Scale 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 clearanceChange 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
Name Time Method 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) managementChange 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 impairmentChange 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/eatingChange 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