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

Phase 4Active Not RecruitingNCT07034222

Ruijin Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease(AD)

Interventions

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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).

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

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

Time frame: Baseline, 6 months, 12 months

Change in Amyloid Burden as Assessed by Centiloid Scale

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

Time frame: Baseline, 6 months, 12 months

Secondary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

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

Time frame: 0-12 months (continuous monitoring)

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

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

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

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

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

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

Data from ClinicalTrials.gov

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