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The main purpose of this study is to evaluate the safety and efficacy of Huperzine A sustained release tablets in patients with mild to moderate Alzheimer's Disease.
The primary aim of this multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled therapeutic trial is to determine whether treatment with huperzine A sustained-release tablets can improve cognitive function in individuals with AD.
A total of 390 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A sustained-release tablets 400µg once a day, huperzine A tablets 200µg twice a day, and placebo.
The study is divided into 2 periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huperzine A Sustained-Release Tablet | Experimental |
| |
| Huperzine A Tablet | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huperzine A | Drug | Sustained-Release Tablet, 400µg once a day, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Interview Based Impression of Change, plus caregiver input | week 24 | |
| Activities of Daily Living | week 24 | |
| Neuropsychiatric Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C050426 | huperzine A |
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| huperzine A | Drug | Tablet, 200µg twice a day, 24 weeks |
|
| Placebo | Drug | placebo orally twice a day |
|
| week 24 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |