Status:

UNKNOWN

Amisulpride Treatment for BPSD in AD Patients

Lead Sponsor:

Tianjin Anding Hospital

Conditions:

BPSD

Amisulpride

Eligibility:

All Genders

Phase:

NA

Brief Summary

Currently, olanzapine is the most widely used and studied drug for the treatment of behavioral and psychological symptoms in patients with Alzheimer's disease, but there are significant side effects. ...

Detailed Description

This study was a randomized, open-label, prospective clinical study in which patients were randomized to receive amisulpride and olanzapine for 8 weeks. Drug efficacy and safety assessments were asses...

Eligibility Criteria

Inclusion

  • It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
  • a total score of MMSE\<24
  • The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
  • Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised

Exclusion

  • People with vascular dementia, frontotemporal dementia, dementia with Lewy bodies or other neurocognitive disorders;
  • Patients with severe brain organic diseases or brain trauma;
  • Physical illnesses associated with severe respiratory, circulatory, immune, and endocrine systems;
  • History of other mental disorders;
  • Those who are allergic to amisulpride or olanzapine;
  • Patients who are contraindicated with amisulpride and olanzapine: pheochromocytoma, prolactin-dependent tumors and narrow-angle glaucoma;

Key Trial Info

Start Date :

December 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2024

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT04341467

Start Date

December 1 2019

End Date

May 1 2024

Last Update

November 16 2022

Active Locations (1)

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Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China, 300222