Clinical trial NCT04341467: Amisulpride Treatment for BPSD in AD Patients
Official title: Amisulpride Versus Olanzapine Treatment for Behavioral and Psychological Symptoms in Patients With Dementia of the Alzheimer Type:A Randomized, Open-label, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPSD
Amisulpride
Olanzapine
Dementia of the Alzheimer Type
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Changes of neuropsychiatric inventory（NPI）scores
timeFrame: baseline, Week 2,4, and 8
Secondary outcomes:
measure: Changes of Clinical global impression-Severity of Illness (CGI-SI) score
timeFrame: baseline, Week 2,4, and 8
measure: Changes of Clinical global impression- global improvement (CGI-GI)
timeFrame: baseline, Week 2,4, and 8
measure: Changes of Mini-Mental State Examination(MMSE) scores.
timeFrame: baseline, Week 2,4, and 8
measure: Changes of Caregiver Burden Inventory (CBI) scores
timeFrame: baseline, Week 2,4, and 8
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: Week 2,4, and 8
measure: Rating scale for extrapyramidal side effects (RSESE)
timeFrame: baseline, Week 2,4, and 8
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: baseline, Week 2,4, and 8
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
References: