Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid HemorrhagePhase 4NCT05560373
The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
A Phase 4 study testing Huperzine A injection, operational treatment, the best basic treatment, operational treatment, the best basic treatment and Huperzine A injection, interventional treatment, the best basic treatment in people with Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
Trial summary
Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Huperzine A injection, operational treatment, the best basic treatment, operational treatment, the best basic treatment and Huperzine A injection, interventional treatment, the best basic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70;
- The patients were proved to be aneurysmal subarachnoid hemorrhage by imaging examination (head CT, CT angiography (CTA), whole brain angiography (DSA));
- Hunt Hess was graded I-III at admission;
- The patients were treated with endovascular therapy or craniotomy and clipping surgery;
- The time from the onset of aSAH symptoms to admission ≤ 72 hours; ⑥ The subject himself or the guardian of the subject knew and voluntarily signed the informed consent form.
Who cannot join
- Non aneurysmal subarachnoid hemorrhage;
- Cognitive dysfunction existed before onset;
- Patients with angina pectoris, bronchial asthma, mechanical intestinal obstruction, liver and kidney insufficiency, and urinary tract obstruction;
- Complicated with other nervous system diseases, including nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, etc.), neuromyelitis optica, epilepsy, central nervous system infection (such as AIDS, syphilis, etc.), brain traumatic dementia, etc;
- Psychotic patients, according to DSM-IV-TR standards, including schizophrenia or other mental diseases, bipolar disorder, major depression or delirium;
- Other cholinesterase inhibitor drugs are being used; ⑦ There are uncorrectable visual and auditory disorders, and neuropsychological tests and scales cannot be completed;
- Have unstable or serious heart, lung, liver, kidney and hematopoietic system diseases;
- Pregnant or lactating women and women of childbearing age without reliable contraception, and there is no evidence of negative pregnancy; ⑩ Patients who cannot be followed up as required during the study period; ⑪ Those who are allergic to the test drug; ⑫ Those who have participated in other clinical trials in recent 3 months; ⑬ Patients who are not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Chen Jingsen, 13666669121
About this study
Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment.
Read the detailed description
Description: This is a randomized, controlled, single center, exploratory clinical trial. The subjects are divided into surgical treatment group and interventional treatment group. Each group is divided into test group and control group. The test group is given huperzine A injection (0.2mg/dose) every day, intramuscular injection, for a total of 8 days, and basic treatment is given at the same time; The control group was given basic treatment, and did not receive other neurotrophic drugs except basic drugs. This clinical trial is to evaluate the effect of huperzine A injection on the improvement of postoperative cognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage.
- Being tested
- Huperzine A injection, operational treatment, the best basic treatment, operational treatment, the best basic treatment, Huperzine A injection, interventional treatment, the best basic treatment, Interventional treatment, the best basic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine A injection, operational treatment, the best basic treatmentDrug
intramuscular
operational treatment, the best basic treatmentOther
other
Huperzine A injection, interventional treatment, the best basic treatmentDrug
intramuscular
Interventional treatment, the best basic treatmentOther
other
| Study group | Role | What they receive |
|---|---|---|
| The operation group-The treatment group | Experimental | after operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d. Receives: Drug: Huperzine A injection, operational treatment, the best basic treatment |
| The operation group-The control group | Other | after operational treatment: ①the best basic treatment Receives: Other: operational treatment, the best basic treatment |
| The intervention group-The treatment group | Experimental | after interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d. Receives: Drug: Huperzine A injection, interventional treatment, the best basic treatment |
| The intervention group-The control group | Other | after interventional treatment: ①the best basic treatment Receives: Other: Interventional treatment, the best basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Status Examination（MMSE ）
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Measured: 90 days after discharge
Secondary outcomes (5)
Hospital anxiety and depression Scale（HADS）
The anxiety and depression subscales of the Hospital Anxiety and Depression Scale were used to screen the anxiety and depression of the subjects before treatment, at the end of medication and at the visit period after discharge, and the intra group and inter group comparisons were made. The higher the score, the more serious the anxiety or depression.
Measured: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
The Short Form-36 Health Survey
Calculate the eight items in the scale. Before and after treatment, the scores of each items and the total score of body and psychology were compared within and between groups.
Measured: Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge
Modified Rankin Score
The functional recovery outcomes before treatment, at the end of medication and at the visit period after discharge were evaluated by using the modified Rankin scale, and compared within and between groups. The higher the score, the worse the functional recovery.
Measured: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
Biological sample detection
Biological samples were tested during the screening period, during the medication period, and after the medication period to obtain drug metabolomics analysis data and disease biomarker data, and intra-group and inter-group comparisons were performed.
Measured: Screening period (day -4 to day 0), day 2, day 3, day 8
Mini Mental Status Examination（MMSE ）
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Measured: Screening period (day -4 to day 0), day2, day 3, day 8, 30 days after discharge and 180 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid HemorrhageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560373
- Sponsor's protocol ID
- SSJJZ-ZDEY-01
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
- ClinicalTrials.gov ID
- NCT05560373
- Acronym / sponsor ID
- SSJJZ-ZDEY-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Sep 2022 (actual)
- 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.
Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment.
Detailed description
Description: This is a randomized, controlled, single center, exploratory clinical trial. The subjects are divided into surgical treatment group and interventional treatment group. Each group is divided into test group and control group. The test group is given huperzine A injection (0.2mg/dose) every day, intramuscular injection, for a total of 8 days, and basic treatment is given at the same time; The control group was given basic treatment, and did not receive other neurotrophic drugs except basic drugs. This clinical trial is to evaluate the effect of huperzine A injection on the improvement of postoperative cognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The operation group-The treatment group | Experimental | Drug: Huperzine A injection, operational treatment, the best basic treatmentafter operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d. |
| The operation group-The control group | Other | Other: operational treatment, the best basic treatmentafter operational treatment: ①the best basic treatment |
| The intervention group-The treatment group | Experimental | Drug: Huperzine A injection, interventional treatment, the best basic treatmentafter interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d. |
| The intervention group-The control group | Other | Other: Interventional treatment, the best basic treatmentafter interventional treatment: ①the best basic treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70;
Key exclusion criteria (8 listed)
- Non aneurysmal subarachnoid hemorrhage;
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 A injection, operational treatment, the best basic treatmentintramuscular | Drug | The operation group-The treatment group |
| operational treatment, the best basic treatmentother | Other | The operation group-The control group |
| Huperzine A injection, interventional treatment, the best basic treatmentintramuscular | Drug | The intervention group-The treatment group |
| Interventional treatment, the best basic treatmentother | Other | The intervention group-The control group |
Primary outcome
Mini Mental Status Examination（MMSE ）
Time frame: 90 days after discharge
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
5 secondary outcomes
Hospital anxiety and depression Scale（HADS）
Time frame: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
The Short Form-36 Health Survey
Time frame: Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge
Modified Rankin Score
Time frame: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
Biological sample detection
Time frame: Screening period (day -4 to day 0), day 2, day 3, day 8
Mini Mental Status Examination（MMSE ）
Time frame: Screening period (day -4 to day 0), day2, day 3, day 8, 30 days after discharge and 180 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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.
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 injection, operational treatment, the best basic treatment, operational treatment, the best basic treatment and Huperzine A injection, interventional treatment, the best basic treatment in people with Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage, run by Wanbangde Pharmaceutical Group 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Jingsen (13666669121, furycjs@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Status Examination（MMSE ） (time frame: 90 days after discharge). 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 17 Aug 2026.