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Alzheimer's Disease(AD)Phase 4NCT07034222

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

A Phase 4 study testing Administer Leqemi 10 mg/kg, every two weeks. in people with Alzheimer's Disease(AD), run by Ruijin Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease(AD)
What is being tested?
Administer Leqemi 10 mg/kg, every two weeks.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Feb 2024to 1 Jan 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Administer Leqemi 10 mg/kg, every two weeks.
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07034222
Study groupRoleWhat they receive
Lecanemab treatment groupExperimentalreceive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes.
Receives: Drug: Administer Leqemi 10 mg/kg, every two weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 months, 12 months

  2. 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

    Measured: Baseline, 6 months, 12 months

Secondary outcomes (7)

  1. 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

    Measured: 0-12 months (continuous monitoring)

  2. 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

    Measured: Baseline, 3 months, 6 months, 12 months

  3. 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

    Measured: Baseline, 3 months, 6 months, 12 months

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

    Mini-Mental State Examination (MMSE) Scale range: 0 (worst) to 30 (best) Higher score indicates better cognitive function

    Measured: Baseline, 3 months, 6 months, 12 months

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

    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

    Measured: Baseline, 3 months, 6 months, 12 months

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

    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)

    Measured: Baseline, 3 months, 6 months, 12 months

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

    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

    Measured: Baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start1 Feb 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07034222
Sponsor's protocol ID
2025025
Status last verified
Jun 2025
First submitted
3 Jun 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41069006

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Administer Leqemi 10 mg/kg, every two weeks. in people with Alzheimer's Disease(AD), run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR) (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07034222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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