Active not recruitingPhase 4

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

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

Lead sponsor

Ruijin Hospital

Asset

Lecanemab

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD / mild AD dementia•CDR global 0.5-1•MMSE 20-30•Brain MRI excludes superficial siderosis, vasogenic edema

Primary endpoints

•Amyloid Burden•Amyloid PET Centiloid

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2025025

NCT IDNCT07034222

Timeline

Milestones

Study start2024-02-01actual

Study first posted2025-06-24actual

Last update posted2025-06-24actual

Primary completion2026-01-01estimated

Study completion2026-01-01estimated

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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).

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Global cognition

Neurodegeneration biomarkers

Function / daily living

Behavior / neuropsychiatric

Tau biomarkers

Caregiver / quality of life

Global cognition

3 endpoints

Secondary/protocol endpoint

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

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

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

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

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

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

4 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint

Change in Amyloid Burden as Assessed by Centiloid Scale

Time frame:Baseline, 6 months, 12 months

Amyloid PET Centiloid

change from baseline, improvement

Secondary/protocol endpoint

Incidence of treatment-emergent adverse events (TEAEs)

Time frame:0-12 months (continuous monitoring)

event count, event

Other/protocol endpoint

Change in Plasma Aβ42/40 Ratio

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

change from baseline, improvement

Tau biomarkers

1 endpoint

Other/protocol endpoint

Change in Plasma Phosphorylated Tau (p-tau181)

Time frame:Baseline, 6 months, 12 months

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Neurodegeneration biomarkers

2 endpoints

Other/protocol endpoint

Change in Plasma Neurofilament Light (NfL)

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

Neurofilament light (NfL)

change from baseline, improvement

Other/protocol endpoint

Change in Plasma Glial Fibrillary Acidic Protein (GFAP)

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

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

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

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

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Kang W, Gao C, Li X, Wang X, Zhong H, Wei Q, Tang Y, Huang P, Shen R, Chen L, Zhang J, Fang R, Wei W, Zhang F, Zhou G, Yuan W, Chen X, Yang Z, Wu Y, Xu W, Zhu S, Zhang L, He N, Fang W, Zhang M, Zhang Y, Ju H, Bai Y, Liu J. Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study. Chin Med J (Engl). 2025 Nov 20;138(22):2907-2916. doi: 10.1097/CM9.0000000000003888. Epub 2025 Oct 27.
PMID41069006via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.