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Amisulpride Treatment for BPSD in AD Patients

China76 participantsStarted 2019-12-01

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Changes of neuropsychiatric inventory（NPI）scores

Timeframe: baseline, Week 2,4, and 8

Trial details

NCT IDNCT04341467

SponsorTianjin Anding Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Contact for this trial

Jie Li, Doctor

022-88188006 tjlijie3827@163.com

View on ClinicalTrials.gov More BPSD trials