Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06741553 for Alzheimer Disease, Mild Cognitive Impairment (MCI) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab 120 Biomarker-Driven
Clinical Trial NCT06741553 is an observational study for Alzheimer Disease, Mild Cognitive Impairment (MCI) that is recruiting. It started on June 28, 2024 with plans to enroll 120 participants. Led by Second Affiliated Hospital, School of Medicine, Zhejiang University, it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on September 3, 2025.
Brief Summary
As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targe...Show More
Official Title
A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population
Conditions
Alzheimer DiseaseMild Cognitive Impairment (MCI)Other Study IDs
- 2024-1113
- 82371190 (Other Grant/Funding Number) (National Natural Science Foundation of China)
NCT ID Number
Start Date (Actual)
2024-06-28
Last Update Posted
2025-09-03
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
120
Study Type
Observational
Status
Recruiting
Keywords
Alzheimer Disease
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Treated Group This is an observational study. The investigators included early AD patients treated with Lecanemab, and evaluated them by plasma, magnetic resonance imaging (MRI) examination and clinical scale. The investigators observed the changes in MRI characteristics and clinical symptoms of patients after Lecanemab administration, evaluated the improvement effect of Lecanemab on cognitive function, and monitored the risk fact...Show More | Lecanemab 10 mg/kg Lecanemab was administered 10mg/kg every two weeks. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
CDR-SB Score | All study subjects underwent Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
MMSE | All study subjects underwent Mini Mental State Examination (MMSE) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). MMSE, with total scores ranging from 0 to 30, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
ADCs-ADL | All study subjects underwent Alzheimer's Disease Cooperative Study-Activity of Daily Life (ADCs-ADL) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 78, can be used to measure activity of daily life changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
NPI | All study subjects underwent Neuropsychiatric Inventory (NPI) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Aβ-PET Burden | All study subjects underwent Aβ positron emission tomography (PET) before the 1st dose (V1) ,at 12 and 18 months after treatment (V26,V39). The investigators quantified participants' Aβ burden using the average cortical standard uptake value ratio (SUVR), that is, tracer uptake in medial orbital frontal, lateral temporal, parietal, anterior cingulate, posterior cingulate, and precuneus regions divided by uptake in the cerebellar reference region. | Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39) |
MRI | All study subjects underwent magnetic resonance imaging (MRI) before the 1st dose (V1) ,at 2, 3, 6,12 and 18 months after treatment. The scan includes T1, T2 fluid attenuated inversion recovery (FLAIR, 5 mm slice thickness), susceptibility weighted imaging (SWI, 1 mm slice thickness) and diffusion weighted imaging (DWI). The MRI scan can be used to meature the study subjects' hippocampus atrophy and white matter hyperintensities and to detect whether adverse events such as amyloid-related imaging abnormalities happen. | Time Frame: MRI tested by baseline before the 1st dose(V1) , at 2, 3, 6, 12 and 18 months after treatment (V5, V7, V14, V25, V39) |
Biospecimen | All study subjects underwent blood collection before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) for routine blood tests, liver and kidney function, plasma biomarkers, and other indicators. Among them, the APOE genotype of subjects will be tested before the 1st dose. | Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
- Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
- Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;
- Completion of APOE gene testing.
- Willingness to use Lecanemab.
- Unable to tolerate MRI scans;
- MRI showing hemorrhagic manifestations, including >4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;
- Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;
- With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityStudy Central Contact
Contact: Yanxing Chen, M.D., +86 188 6840 1257, [email protected]
1 Study Locations in 1 Countries
Zhejiang
Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Yanxing Chen, MD, Contact, +86 188 6840 1257, [email protected]
Recruiting