The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study

Wanbangde Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage

Treatments: Other: Interventional treatment, the best basic treatment; Other: operational treatment, the best basic treatment; Drug: Huperzine A injection, interventional treatment, the best basic treatment; Drug: Huperzine A injection, operational treatment, the best basic treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05560373

20220784

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

The operation group-The treatment group

Experimental group

Description:

after operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.

Treatment:

Drug: Huperzine A injection, operational treatment, the best basic treatment

The operation group-The control group

Other group

Description:

after operational treatment: ①the best basic treatment

Treatment:

Other: operational treatment, the best basic treatment

The intervention group-The treatment group

Experimental group

Description:

after interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.

Treatment:

Drug: Huperzine A injection, interventional treatment, the best basic treatment

The intervention group-The control group

Other group

Description:

after interventional treatment: ①the best basic treatment

Treatment:

Other: Interventional treatment, the best basic treatment