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Amisulpride Treatment for BPSD in AD Patients
Amisulpride Versus Olanzapine Treatment for Behavioral and Psychological Symptoms in Patients With Dementia of the Alzheimer Type:A Randomized, Open-label, Prospective Study
Lead sponsor
Assets
Amisulpride / Olanzapine
Listed sites
1
Recruiting sites
1
Enrollment
76
estimated
Study population
Alzheimer’s disease
Key I/E criterion
•MMSE ≤24
Primary endpoint
•Neuropsychiatric Inventory (NPI)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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;
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChanges of Mini-Mental State Examination(MMSE) scores.
Time frame:baseline, Week 2,4, and 8
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Behavior / neuropsychiatric
1 endpointChanges of neuropsychiatric inventory(NPI)scores
Time frame:baseline, Week 2,4, and 8
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Caregiver / quality of life
1 endpointChanges of Caregiver Burden Inventory (CBI) scores
Time frame:baseline, Week 2,4, and 8
change from baseline, improvement
Other clinical outcomes
2 endpointsChanges of Clinical global impression-Severity of Illness (CGI-SI) score
Time frame:baseline, Week 2,4, and 8
change from baseline, improvement
Changes of Clinical global impression- global improvement (CGI-GI)
Time frame:baseline, Week 2,4, and 8
change from baseline, improvement
Other (unclassified)
3 endpointsTreatment Emergent Symptom Scale (TESS)
Time frame:Week 2,4, and 8
descriptive
Rating scale for extrapyramidal side effects (RSESE)
Time frame:baseline, Week 2,4, and 8
descriptive
Abnormal Involuntary Movement Scale (AIMS)
Time frame:baseline, Week 2,4, and 8
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.