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UnknownPhase 2 / PHASE3

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

Asset

Huperzine A

Listed sites

1

Recruiting sites

1

Enrollment

390

estimated

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE ≤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

Org study IDLY200901-04
NCT IDNCT01282619

Timeline

Milestones

Study start2010-05 (month precision)
Study first posted2011-01-25estimated
Last update posted2011-01-25estimated
Primary completion2012-06estimated (month precision)
Study completion2012-06estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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
Behavior / neuropsychiatric
1
Caregiver / quality of life
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Activities of Daily Living

Time frame:week 24

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory

Time frame:week 24

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Clinician's Interview Based Impression of Change, plus caregiver input

Time frame:week 24

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time frame:week 24

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.