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Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease
A Multi-Center, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Study to Evaluate the Safety and Efficacy of Huperzine A Sustained-Release Tablets in Patients With Mild to Moderate Alzheimer's Disease
Lead sponsor
Asset
Huperzine A
Listed sites
1
Recruiting sites
1
Enrollment
390
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE ≤24
Primary endpoint
•Alzheimer's Disease Assessment Scale - Cognitive Subscale
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male/female patient aged between 50 and 85
2. Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria
3. Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;
4. CT or MRI scan excluding another structural brain disease;
5. Hachinski Ischemic Score < 4
6. Hamilton Depression Scale ≤10
7. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study
Exclusion criteria
1. Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
2. Epileptic Patient
3. Severe liver or renal disease
4. Resting pulse less than 50
5. Mechanical intestinal obstruction patient
6. History of stroke
7. History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease
8. Cognitive damage caused by alcohol or substance abuse
9. Disable to participate or cooperate in the protocol
10. Use of any agent for the treatment of dementia within 2 weeks of randomization
11. Use of another investigational agent within 3 months of screening
12. Be sensitive to Huperzine A or other ACHEIs.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Function / daily living
1 endpointActivities of Daily Living
Time frame:week 24
descriptive
Behavior / neuropsychiatric
1 endpointNeuropsychiatric Inventory
Time frame:week 24
Neuropsychiatric Inventory (NPI)
descriptive
Caregiver / quality of life
1 endpointClinician's Interview Based Impression of Change, plus caregiver input
Time frame:week 24
descriptive
Other (unclassified)
1 endpointAlzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame:week 24
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.