Alzheimer's Disease(AD)
Conditions
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.
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.
Interventions
DRUGAdminister Leqemi 10 mg/kg, every two weeks.
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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR) | Baseline, 6 months, 12 months | 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 |
| Change in Amyloid Burden as Assessed by Centiloid Scale | Baseline, 6 months, 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function as Assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) | Baseline, 3 months, 6 months, 12 months | Comprehensive neuropsychological test battery Scale range: 0 (best) to 90 (worst) Higher score indicates greater cognitive impairment |
| Change in Cognitive Function as Assessed by Mini-Mental State Examination (MMSE) | Baseline, 3 months, 6 months, 12 months | Mini-Mental State Examination (MMSE) Scale range: 0 (worst) to 30 (best) Higher score indicates better cognitive function |
| Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) | Baseline, 3 months, 6 months, 12 months | 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 |
| Change in Functional Abilities as Assessed by the Alzheimer's Disease Cooperative Study-Activities of Daily Living for Mild Cognitive Impairment (ADCS MCI-ADL) | Baseline, 3 months, 6 months, 12 months | 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) |
| Change in Caregiver Burden as Assessed by the Zarit Burden Interview (ZBI) | Baseline, 3 months, 6 months, 12 months | 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 |
| Incidence of treatment-emergent adverse events (TEAEs) | 0-12 months (continuous monitoring) | 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 |
| Change in Cognitive Function as Assessed by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) | Baseline, 3 months, 6 months, 12 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Glial Fibrillary Acidic Protein (GFAP) | Baseline, 3 months, 6 months, 12 months | Single Molecule Array (Simoa™, Quanterix) digital immunoassay |
| Change in Plasma Neurofilament Light (NfL) | Baseline, 3 months, 6 months, 12 months | Single Molecule Array (Simoa™, Quanterix) digital immunoassay |
| Change in Plasma Phosphorylated Tau (p-tau181) | Baseline, 6 months, 12 months | Single Molecule Array (Simoa™, Quanterix) digital immunoassay |
| Change in Plasma Aβ42/40 Ratio | Baseline, 3 months, 6 months, 12 months | Technology: Single Molecule Array (Simoa™, Quanterix) digital immunoassay |
Countries
China
Outcome results
None listed