Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

Not yet recruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2028

Conditions
Alzheimer Disease (AD)Alzheimer DementiaMild Cognitive Impairment (MCI)
Interventions
BIOLOGICAL

Lecanemab 10 mg/kg

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. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.

DRUG

Conventional anti-dementia treatment group

Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

NCT07152418 - Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research | Biotech Hunter | Biotech Hunter