Clinical trial NCT05560373: The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Official title: The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Wanbangde Pharmaceutical Group Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2022-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mini Mental Status Examination（MMSE ）
timeFrame: 90 days after discharge
Secondary outcomes:
measure: Hospital anxiety and depression Scale（HADS）
timeFrame: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
measure: The Short Form-36 Health Survey
timeFrame: Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge
measure: Modified Rankin Score
timeFrame: Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
measure: Biological sample detection
timeFrame: Screening period (day -4 to day 0), day 2, day 3, day 8
measure: Mini Mental Status Examination（MMSE ）
timeFrame: Screening period (day -4 to day 0), day2, day 3, day 8, 30 days after discharge and 180 days after discharge
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: