Alzheimer Dementia, Alzheimer Disease (AD), MCI-AD, Early Stage Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, lecanemab, different doses
Brief summary
This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.
Interventions
Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL.
DRUGLecanemab 5-10mg/kg
Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria for AD-derived MCI or early AD \[Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology\] * Male or female * 50-85 years old * Not currently participating in other research studies * Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form * Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study
Exclusion criteria
* Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc. * Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure. * Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases. * Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc. * Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aβ-PET centiloid values | Baseline, 18 months | Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months | Baseline, 6 months, 12 months, 18 months | Assessment of the Statistical Difference in CDR Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group |
| Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months | Baseline, 6 months, 12 months, 18 months | Assessment of the Statistically Significant Difference in MMSE Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group |
| Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months | Baseline, 6 months, 12 months, 18 months | Assessment of the Statistically Significant Difference in MoCA Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group |
| Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months | Baseline, 6 months, 12 months, 18 months | Assessment of the Statistically Significant Difference in NPI Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group |
Countries
China
Contacts
CONTACTJiong Zhou
CONTACTYaping Yan
Outcome results
None listed