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Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease

L

Luye Pharma Group

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: huperzine A
Drug: Placebo
Drug: Huperzine A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01282619
LY200901-04

Details and patient eligibility

About

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.

Full description

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:

  1. A two-week placebo run-in period
  2. A 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.

Enrollment

390 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

390 participants in 3 patient groups, including a placebo group

Huperzine A Sustained-Release Tablet
Experimental group
Treatment:
Drug: Huperzine A
Huperzine A Tablet
Active Comparator group
Treatment:
Drug: huperzine A
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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