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

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Huperzine A

huperzine A

Placebo

About this trial

This is an interventional prevention trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male/female patient aged between 50 and 85
Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria
Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;
CT or MRI scan excluding another structural brain disease;
Hachinski Ischemic Score < 4
Hamilton Depression Scale ≤10
Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.

Exclusion Criteria:

Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
Epileptic Patient
Severe liver or renal disease
Resting pulse less than 50
Mechanical intestinal obstruction patient
History of stroke
History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease
Cognitive damage caused by alcohol or substance abuse
Disable to participate or cooperate in the protocol
Use of any agent for the treatment of dementia within 2 weeks of randomization
Use of another investigational agent within 3 months of screening
Be sensitive to Huperzine A or other ACHEIs.

Sites / Locations

Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Huperzine A Sustained-Release Tablet

Huperzine A Tablet

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale

Secondary Outcome Measures

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

Activities of Daily Living

Neuropsychiatric Inventory

Full Information

NCT ID

NCT01282619

First Posted

January 24, 2011

Last Updated

January 24, 2011

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01282619

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huperzine A Sustained-Release Tablet

Arm Type

Experimental

Arm Title

Huperzine A Tablet

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Huperzine A

Intervention Description

Sustained-Release Tablet, 400µg once a day, 24 weeks

Intervention Type

Drug

Intervention Name(s)

huperzine A

Intervention Description

Tablet, 200µg twice a day, 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo orally twice a day

Primary Outcome Measure Information:

Title

Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time Frame

week 24

Secondary Outcome Measure Information:

Title

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

Time Frame

week 24

Title

Activities of Daily Living

Time Frame

week 24

Title

Neuropsychiatric Inventory

Time Frame

week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male/female patient aged between 50 and 85 Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16; CT or MRI scan excluding another structural brain disease; Hachinski Ischemic Score < 4 Hamilton Depression Scale ≤10 Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study. Exclusion Criteria: Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc. Epileptic Patient Severe liver or renal disease Resting pulse less than 50 Mechanical intestinal obstruction patient History of stroke History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease Cognitive damage caused by alcohol or substance abuse Disable to participate or cooperate in the protocol Use of any agent for the treatment of dementia within 2 weeks of randomization Use of another investigational agent within 3 months of screening Be sensitive to Huperzine A or other ACHEIs.

Facility Information:

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang

Phone

861085865101

12. IPD Sharing Statement

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

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