Back to resultsAmisulpride Treatment for BPSD in AD Patients
Primary Purpose
BPSD, Amisulpride, Olanzapine
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amisulpride
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for BPSD
Eligibility Criteria
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;
Sites / Locations
- Tianjin Anding HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amisulpride group
Olanzapine group
Arm Description
The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04341467
First Posted
December 27, 2019
Last Updated
November 15, 2022
Sponsor
Tianjin Anding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04341467
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPSD, Amisulpride, Olanzapine, Dementia of the Alzheimer Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amisulpride group
Arm Type
Experimental
Arm Description
The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
Arm Title
Olanzapine group
Arm Type
Active Comparator
Arm Description
The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Other Intervention Name(s)
Solian
Intervention Description
The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Oulanning
Intervention Description
The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
Primary Outcome Measure Information:
Title
Changes of neuropsychiatric inventory（NPI）scores
Description
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.
Time Frame
baseline, Week 2,4, and 8
Secondary Outcome Measure Information:
Title
Changes of Clinical global impression-Severity of Illness (CGI-SI) score
Description
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
Time Frame
baseline, Week 2,4, and 8
Title
Changes of Clinical global impression- global improvement (CGI-GI)
Description
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
Time Frame
baseline, Week 2,4, and 8
Title
Changes of Mini-Mental State Examination(MMSE) scores.
Description
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.
Time Frame
baseline, Week 2,4, and 8
Title
Changes of Caregiver Burden Inventory (CBI) scores
Description
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.
Time Frame
baseline, Week 2,4, and 8
Title
Treatment Emergent Symptom Scale (TESS)
Description
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.
Time Frame
Week 2,4, and 8
Title
Rating scale for extrapyramidal side effects (RSESE)
Description
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.
Time Frame
baseline, Week 2,4, and 8
Title
Abnormal Involuntary Movement Scale (AIMS)
Description
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.
Time Frame
baseline, Week 2,4, and 8
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, Doctor
Phone
022-88188006
Email
tjlijie3827@163.com
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Doctor
Phone
+86 022 88188006
Email
tjlijie3827@163.com
12. IPD Sharing Statement
Learn more about this trial
Amisulpride Treatment for BPSD in AD Patients
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