Alzheimer's DiseasePhase 2/3NCT01282619
Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease
A Phase 2/3 study testing Huperzine A in people with Alzheimer's Disease, run by Shandong Luye Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Huperzine A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Wang, 861085865101
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Huperzine A, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine ADrug
Sustained-Release Tablet, 400µg once a day, 24 weeks
huperzine ADrug
Tablet, 200µg twice a day, 24 weeks
PlaceboDrug
placebo orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Huperzine A Sustained-Release Tablet | Experimental | Not described Receives: Drug: Huperzine A |
| Huperzine A Tablet | Active comparator | Not described Receives: Drug: huperzine A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Measured: week 24
Secondary outcomes (3)
Clinician's Interview Based Impression of Change, plus caregiver input
Measured: week 24
Activities of Daily Living
Measured: week 24
Neuropsychiatric Inventory
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282619
- Sponsor's protocol ID
- LY200901-04
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01282619
- Acronym / sponsor ID
- LY200901-04
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Huperzine A Sustained-Release Tablet | Experimental | Drug: Huperzine A |
| Huperzine A Tablet | Active comparator | Drug: huperzine A |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huperzine ASustained-Release Tablet, 400µg once a day, 24 weeks | Drug | Huperzine A Sustained-Release Tablet |
| huperzine ATablet, 200µg twice a day, 24 weeks | Drug | Huperzine A Tablet |
| Placeboplacebo orally twice a day | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: week 24
3 secondary outcomes
Clinician's Interview Based Impression of Change, plus caregiver input
Time frame: week 24
Activities of Daily Living
Time frame: week 24
Neuropsychiatric Inventory
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Huperzine A in people with Alzheimer's Disease, run by Shandong Luye Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale - Cognitive Subscale (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.