This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.
The subject voluntarily agrees to participate in the study and signs the informed consent form jointly with a legally authorized representative (LAR). If the subject is unable to sign due to cognitive impairment or other reasons, the signature field for the subject may be left blank, with the reason specified and signed by the LAR. In such cases, the LAR must sign the informed consent form on behalf of the subject.
Aged ≥50 and ≤85 years, male or female.
Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia according to the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) guidelines.
Has experienced memory impairment for at least 12 months, with a chronic and progressively worsening course.
Subjects who are allergic to the active ingredient or excipients of huperzine A controlled-release tablets or donepezil, or those with lactose intolerance.
Presence of lesions indicating large-area cerebral infarction;
Infarcts in critical brain regions (e.g., thalamus, hippocampus, entorhinal cortex, parahippocampal gyrus, angular gyrus, cortical or subcortical gray matter nuclei);
More than two infarcts with a diameter >2 cm, and deemed by the investigator to impact cognitive assessments;
Parallel
Huperzine A Controlled-Release Tablets
DrugDuring the trial, the patients should take huperzine A controlled-release tablets in the morning
Donepezil hydrochloride tablets
DrugDuring the trial, the patients should take donepezil hydrochloride tablets before going to bed in the evening
Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo
DrugDuring the trial, the patients should take huperzine A controlled-release tablets placebo in the morning and donepezil hydrochloride tablets placebo before going to bed in the evening
ADAS-Cog11
ADAS-Cog11: Alzheimer's Disease Assessment Scale-Cognitive Subscale. Score range: 0-70. Lower = better
ADCS-ADL
ADCS-ADL: Alzheimer's Disease Cooperative Study - Activities of Daily Living. Score range: 0-78. Higher= better
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