Clinical trial NCT06741553: Prospective Cohort Study of Patients with Early Alzheimer's Disease Treated with Lecanemab
Official title: A Study That Uses an Organized System to Prospectively Collect Uniform Data from a Defined Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment (MCI)
Keywords: Alzheimer Disease
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 120
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included early AD patients treated with Lecanemab at the Second Affiliated Hospital of Zhejiang University School of Medicine.

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, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CDR-SB Score
timeFrame: CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
Secondary outcomes:
measure: Aβ-PET Burden
timeFrame: Aβ-PET tested by baseline before the 1st dose(V1) and at 12 months after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Zhejiang University School of Medicine Second Affiliated Hospital
name: Baorong Zhang, M.D.
role: STUDY_DIRECTOR
References: