This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.
Dose-Escalation Phase: A traditional "3+3" dose-escalation design will be used. Subjects will be sequentially assigned to one of three dose groups (0.75 × 10¹⁰ Particles/mL, 1.50 × 10¹⁰ Particles/mL, 3.00 × 10¹⁰ Particles/mL; 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks). Three subjects will be enrolled in each dose group. Escalation to the next dose level will proceed if no Dose-Limiting Toxicity (DLT) is observed in these 3 subjects. If 1 out of 3 subjects experiences a DLT, an additional 3 subjects will be enrolled in the same dose group. Escalation to the next dose level will proceed if no DLT is observed in these additional 3 subjects. Expansion Cohort Phase: 24 subjects will be randomized in a 1:1 ratio to either the experimental group (exosome group) or the control group (exosome mimetic group). The dose for the experimental group in this phase will be determined by the Safety Review Committee based on the safety and efficacy data from the dose-escalation phase. The dosing frequency and duration will be 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Specification: 2.0 mL/vial. Particle concentration: (Low) 0.75 × 10¹⁰ Particles/mL, (Medium) 1.50 × 10¹⁰ Particles/mL, (High) 3.00 × 10¹⁰ Particles/mL.
Specification: 2.0 mL/vial.
Xuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGIncidence of serious adverse events
The proportion of patients who experienced severe adverse events.
Time frame: 24 weeks (±1 week)
Alzheimer's Disease Assessment Scale-cog
Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) score
Time frame: 24 weeks (±1 week)
Incidence of adverse events
The proportion of patients who experienced adverse events.
Time frame: 24 weeks (±1 week)
Incidence of severe adverse events
The proportion of patients who experienced severe adverse events.
Time frame: 12 weeks (±1 week)
Incidence of adverse events
The proportion of patients who experienced adverse events.
Time frame: 12 weeks (±1 week)
Incidence of severe adverse events
The proportion of patients who experienced severe adverse events.
Time frame: 4 weeks (±3 days)
Incidence of adverse events
The proportion of patients who experienced adverse events.
Time frame: 4 weeks (±3 days)
Alzheimer's disease assessment scale-cognitive section(ADAS-cog)
Change from baseline in ADAS-cog score
Time frame: 12 weeks (±1 week)
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Mini-Mental State Examination (MMSE)
Change from baseline in Mini-Mental State Examination (MMSE) score
Time frame: 24 weeks (±1 week)
Montreal Cognitive Assessment (MoCA)
Change from baseline in Montreal Cognitive Assessment (MoCA) score
Time frame: 24 weeks (±1 week)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
Time frame: 24 weeks (±1 week)
Neuropsychiatric Inventory (NPI)
Change from baseline in Neuropsychiatric Inventory (NPI) score
Time frame: 24 weeks (±1 week)