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

NCT05560373 | Unknown Phase 4

• 1 other identifier: 20220784
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after discharge

Secondary Outcomes (5)

• Hospital anxiety and depression Scale（HADS）

  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

  Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge

• Modified Rankin Score

  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

  Screening period (day -4 to day 0), day 2, day 3, day 8

• Mini Mental Status Examination（MMSE ）

  Screening period (day -4 to day 0), day2, day 3, day 8, 30 days after discharge and 180 days after discharge

Study Arms (4)

The operation group-The treatment group

EXPERIMENTAL

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

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

The operation group-The control group

OTHER

after operational treatment: ①the best basic treatment

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.

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

The intervention group-The control group

OTHER

after interventional treatment: ①the best basic treatment

Other: Interventional treatment, the best basic treatment

Interventions

Huperzine A injection, operational treatment, the best basic treatment DRUG

intramuscular

The operation group-The treatment group

operational treatment, the best basic treatment OTHER

other

The operation group-The control group

Huperzine A injection, interventional treatment, the best basic treatment DRUG

intramuscular

The intervention group-The treatment group

Interventional treatment, the best basic treatment OTHER

other

The intervention group-The control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wanbangde Pharmaceutical Group Co., LTD: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

huperzine A

Central Study Contacts

Chen Jingsen

CONTACT

13666669121; furycjs@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: September 30, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)