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
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