12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease
A 12-month Single-arm Real-world Study to Determine the Safety and Efficacy of Lecanemab in Patients With Early Alzheimer's Disease
Sponsor: Ruijin Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR)
Time frame: Baseline, 6 months, 12 months
Change in Amyloid Burden as Assessed by Centiloid Scale
Time frame: Baseline, 6 months, 12 months
Secondary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Change in Cognitive Function as Assessed by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Change in Cognitive Function as Assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
Eligibility Criteria
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. Exclusion Criteria: \- MRI/SWI exclusionary findings: …
Read full criteria on CT.gov →✦ Analyst Commentary
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