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

NCT07034222 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2025025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease(AD)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline, 6 months, 12 months

Secondary Outcomes (7)

• Incidence of treatment-emergent adverse events (TEAEs)

  0-12 months (continuous monitoring)

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

  Baseline, 3 months, 6 months, 12 months

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

  Baseline, 3 months, 6 months, 12 months

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

  Baseline, 3 months, 6 months, 12 months

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

  Baseline, 3 months, 6 months, 12 months

Other Outcomes (4)

• Change in Plasma Aβ42/40 Ratio

  Baseline, 3 months, 6 months, 12 months

• Change in Plasma Phosphorylated Tau (p-tau181)

  Baseline, 6 months, 12 months

• Change in Plasma Neurofilament Light (NfL)

  Baseline, 3 months, 6 months, 12 months

Study Arms (1)

Lecanemab treatment group

EXPERIMENTAL

receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes.

Drug: Administer Leqemi 10 mg/kg, every two weeks.

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.

Lecanemab treatment group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 41069006 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Neurology

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 24, 2025
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)