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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amisulpride group | Experimental | The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d. |
|
| Olanzapine group | Active Comparator | The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride | Drug | The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of neuropsychiatric inventory（NPI）scores | The change from baseline neuropsychiatric inventory (NPI) items at week 2,4,and 8. Assess the frequency and severity of psychiatric symptoms, including delusions, hallucinations, aggression attacks, depression, anxiety, elevated emotions, indifferent emotions, de-inhibition, agitation, abnormal behaviors, sleep / night behaviors, appetite / eating disorders,the maximum scores is 144.The higher score are considered the psychiatric symptoms more serious. | baseline, Week 2,4, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Clinical global impression-Severity of Illness (CGI-SI) score | The change from baseline Clinical global impression-Severity of Illness (CGI-SI) score. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen The change from baseline Clinical global impression-Severity of Illness (CGI-SI) score. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Li, Doctor | Contact | 022-88188006 | tjlijie3827@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Anding Hospital | Recruiting | Tianjin | Tianjin Municipality | 300222 | China |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Olanzapine | Drug | The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d. |
|
|
| baseline, Week 2,4, and 8 |
| Changes of Clinical global impression- global improvement (CGI-GI) | The change from baseline Clinical global impression- global improvement (CGI-GI) items at week 2,4,and 8. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen | baseline, Week 2,4, and 8 |
| Changes of Mini-Mental State Examination(MMSE) scores. | The change from baseline Mini-Mental State Examination(MMSE) items at week 2,4,and 8.The content includes time orientation, location orientation, immediate memory of language, attention and calculation, short-term memory, physical naming, language repeating, reading comprehension, speech expression and graphic description. 0 to 30 points, the lower the score, the more severe the cognitive impairment. | baseline, Week 2,4, and 8 |
| Changes of Caregiver Burden Inventory (CBI) scores | The change from baseline Caregiver Burden Inventory (CBI) items at week 2,4,and 8.The questionnaire contains 5 dimensions: time-dependent burden, development-restricted burden, physical burden, social burden, and emotional burden. The total score is 96 points. The higher the score, the heavier the burden. | baseline, Week 2,4, and 8 |
| Treatment Emergent Symptom Scale (TESS) | The scale collection includes 33 items of consciousness disorder, constipation, tremor, etc., to assess the adverse drug reactions and their severity.This table is used to evaluate 33 items of common consciousness disorder, constipation, tremor, etc. based on the adverse drug reactions. Each item is scored according to the severity of the adverse drug reactions. This scale does not need to be evaluated at baseline. | Week 2,4, and 8 |
| Rating scale for extrapyramidal side effects (RSESE) | Assessment of extrapyramidal reactions and their severity at various time points.Assess the severity of 9 aspects of gait, falling arms, shaking shoulders, elbow rigidity, fixed posture or wrist rigidity, leg swings, head and neck movements, tapping between eyebrows, drooling，The total score is 36 points. The higher the score, the more severe extrapyramidal side effects. | baseline, Week 2,4, and 8 |
| Abnormal Involuntary Movement Scale (AIMS) | Assesses whether patients have involuntary movements and their severity in the face, limbs, and trunk at various time points.Assess facial movements, body movements, and trunk movements for involuntary movements and severity. A total score of 2 or more is masculine gender. | baseline, Week 2,4, and 8 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |