NCT04341467

Amisulpride Treatment for BPSD in AD Patients

Amisulpride Versus Olanzapine Treatment for Behavioral and Psychological Symptoms in Patients With Dementia of the Alzheimer Type:A Randomized, Open-label, Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. Amisulpride is a new antipsychotic that not only controls mental symptoms but also improves cognitive function. Therefore, the aim of this study was to evaluate the effectiveness and tolerability of both amisulpride and Olanzapine for treating the behavioral and psychological symptoms of dementia in patients with dementia of the Alzheimer type.

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 assessed at baseline, 2 weekends, 4 weekends, and 8 weekends.

Conditions

• BPSD
• Amisulpride
• Olanzapine
• Dementia of the Alzheimer Type

Interventions

Type	Name	Description
DRUG	Amisulpride	The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
DRUG	Olanzapine	The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2020-04-10
• Last updated: 2022-11-16

Locations

1 site across 1 country: China