BPSDNCT04341467
Amisulpride Treatment for BPSD in AD Patients
A study testing Amisulpride and Olanzapine in people with BPSD and Amisulpride, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- BPSD, Amisulpride, Olanzapine
- What is being tested?
- Amisulpride and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300222
Jie Li, Doctor, +86 022 88188006, tjlijie3827@163.com
About this study
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
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.
Read the 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.
- Conditions
- BPSD, Amisulpride, Olanzapine, Dementia of the Alzheimer Type
- Being tested
- Amisulpride, Olanzapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
Also called Solian
The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
OlanzapineDrug
Also called Oulanning
The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride group | Experimental | The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d. Receives: Drug: Amisulpride |
| Olanzapine group | Active comparator | The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, Week 2,4, and 8
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, Week 2,4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Dec 2019
- Primary completion1 Dec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341467
- Sponsor's protocol ID
- AMI-2019-BPSD
- Status last verified
- Oct 2022
- First submitted
- 27 Dec 2019
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04341467
- Acronym / sponsor ID
- AMI-2019-BPSD
- Conditions
- BPSD, Amisulpride, Olanzapine, Dementia of the Alzheimer Type
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amisulpride group | Experimental | Drug: AmisulprideThe initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d. |
| Olanzapine group | Active comparator | Drug: OlanzapineThe initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmisulprideAlso: SolianThe initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d. | Drug | Amisulpride group |
| OlanzapineAlso: OulanningThe initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d. | Drug | Olanzapine group |
Primary outcome
Changes of neuropsychiatric inventory（NPI）scores
Time frame: baseline, Week 2,4, and 8
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.
7 secondary outcomes
Changes of Clinical global impression-Severity of Illness (CGI-SI) score
Time frame: baseline, Week 2,4, and 8
Changes of Clinical global impression- global improvement (CGI-GI)
Time frame: baseline, Week 2,4, and 8
Changes of Mini-Mental State Examination(MMSE) scores.
Time frame: baseline, Week 2,4, and 8
Changes of Caregiver Burden Inventory (CBI) scores
Time frame: baseline, Week 2,4, and 8
Treatment Emergent Symptom Scale (TESS)
Time frame: Week 2,4, and 8
Rating scale for extrapyramidal side effects (RSESE)
Time frame: baseline, Week 2,4, and 8
Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline, Week 2,4, and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amisulpride and Olanzapine in people with BPSD and Amisulpride, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, Doctor (022-88188006, tjlijie3827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of neuropsychiatric inventory（NPI）scores (time frame: baseline, Week 2,4, and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.