Mild Cognitive ImpairmentPhase 4NCT02931136
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
A Phase 4 study testing Huperzine A in people with Mild Cognitive Impairment and Biomarker, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Biomarker, Diagnosis
- What is being tested?
- Huperzine A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2019to Dec 2025
- Phase
- Phase 4
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- memory complaint, preferably corroborated by a spouse or relative.
- objective memory impairment.
- normal general cognitive function.
- intact activities of daily living.
- absence of dementia.
- the positive of brain senile plaque.
Who cannot join
- more than two lacuna ischemia (of diameter < 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence.
- other type of dementia except AD
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Weimin Yang, M.D., 00862164387250, yang08631@163.com
About this study
The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.
Read the detailed description
This is a randmized, double-blind, placebo-controll study.
- Conditions
- Mild Cognitive Impairment, Biomarker, Diagnosis, Treatment
- Being tested
- Huperzine A, Placebo
- Medical subject headings
- Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine ADrug
Also called shuang yi ping
The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
PlaceboDrug
The participants will treatment by the placebo in 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | Huperzine A treatment. Receives: Drug: Huperzine A |
| Placebo group | Placebo comparator | The placebo in 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average annual conversion rate in patients of MCI due to AD convert to the AD.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startNov 2019 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaoshifu, Shanghai Mental Health Center
- Investigators
- Shifu Xiao, M.D., Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931136
- Sponsor's protocol ID
- Shanghai Mental Health Center
- Status last verified
- Apr 2019
- First submitted
- 8 Oct 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
- ClinicalTrials.gov ID
- NCT02931136
- Acronym / sponsor ID
- Shanghai Mental Health Center
- Conditions
- Mild Cognitive Impairment, Biomarker, Diagnosis, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Oct 2016 (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 purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.
Detailed description
This is a randmized, double-blind, placebo-controll study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: Huperzine AHuperzine A treatment. |
| Placebo group | Placebo comparator | Drug: PlaceboThe placebo in 52 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- memory complaint, preferably corroborated by a spouse or relative.
- objective memory impairment.
- normal general cognitive function.
- intact activities of daily living.
- absence of dementia.
Key exclusion criteria (2 listed)
- more than two lacuna ischemia (of diameter < 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence.
- other type of dementia except AD
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 AAlso: shuang yi pingThe participants will treatment by the Huperzine A 200 ug/day in 52 weeks. | Drug | treatment group |
| PlaceboThe participants will treatment by the placebo in 52 weeks. | Drug | Placebo group |
Primary outcome
The average annual conversion rate in patients of MCI due to AD convert to the AD.
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Yes
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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.
Shifu Xiao, M.D., Ph.D. principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huperzine A in people with Mild Cognitive Impairment and Biomarker, run by Shanghai Mental Health Center 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 6 inclusion and 2 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 16 Apr 2019. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Tao Wang, M.D., Ph.D. (00862164387250 ext. 73440, wtshhwy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average annual conversion rate in patients of MCI due to AD convert to the AD. (time frame: 52 weeks). 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 16 Apr 2019.