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A clinical study plan for using botulinum toxin type A to intervene in mild cognitive impairment

A clinical study plan for using botulinum toxin type A to intervene in mild cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090992
Enrollment
Unknown
Registered
2024-10-17
Start date
2024-02-27
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Interventions

Botulinum toxin-A group :100U of type A botulinum toxin is dissolved in 2ml of physiological saline, and using a 1ml syringe, perform multi-point injections (20 points) on the patients forehead and bi
placebo group:The placebo group received 2ml of 0.9% sodium chloride injection, which was injected at 20 points on the patients forehead and bilateral temporal regions using a 1ml syringe. The injecti

Sponsors

the Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for mild cognitive impairment; 2) 85 years old = 45 years old; 3) Not receiving treatment or currently experiencing poor treatment outcomes; 4) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Allergic to type A botulinum toxin drugs; 2) Merge neuromuscular diseases, such as myasthenia gravis, motor neuron disease, etc; 3) Patients with severe metabolic disorders, such as liver and kidney dysfunction, hyperthyroidism/hypothyroidism, etc; 4) Dementia patients and those who are currently taking and unwilling to stop taking non research provided drugs that affect cognitive function; 5) Infection or fever at the injection site; 6) Mental disorders; 7) Patients with severe brain diseases, such as head trauma, mass, intracranial infection, epilepsy, or other inflammatory lesions of the central nervous system; 8) There are other reasons that can cause cognitive impairment (such as excessive alcohol consumption, drug abuse, etc.); 9) MRI contraindications; 10) Patients with severe anxiety and depression; 11) Those who are unwilling or unable to cooperate in completing relevant scales.

Design outcomes

Primary

MeasureTime frame
MMSE;MoCa;ACE-?;

Secondary

MeasureTime frame
HAMA;HAMD;SAS;SDS;ADL;

Countries

China

Contacts

Public ContactWeifeng Luo

Department of Neurology,the Second Affiliated Hospital of Soochow University

lwfwxx@126.com+86 138 1484 1508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026