Amisulpride Treatment for BPSD in AD Patients

Tianjin Anding Hospital

Status: Enrolling

Conditions: Amisulpride; Dementia of the Alzheimer Type; BPSD; Olanzapine

Treatments: Drug: Amisulpride; Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT04341467

AMI-2019-BPSD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
2. a total score of MMSE<24
3. The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
4. 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Amisulpride group

Experimental group

Description:

The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.

Treatment:

Drug: Amisulpride

Olanzapine group

Active Comparator group

Description:

The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.

Treatment:

Drug: Olanzapine