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UnknownPhase NA

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

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

Org study IDAMI-2019-BPSD
NCT IDNCT04341467

Timeline

Milestones

Study start2019-12-01actual
Study first posted2020-04-10actual
Last update posted2022-11-16actual
Primary completion2023-12-01estimated
Study completion2024-05estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
3
Other clinical outcomes
2
Global cognition
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Changes 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 endpoint
Primary/protocol endpoint

Changes 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 endpoint
Secondary/protocol endpoint

Changes of Caregiver Burden Inventory (CBI) scores

Time frame:baseline, Week 2,4, and 8

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Changes of Clinical global impression-Severity of Illness (CGI-SI) score

Time frame:baseline, Week 2,4, and 8

change from baseline, improvement

Secondary/protocol endpoint

Changes of Clinical global impression- global improvement (CGI-GI)

Time frame:baseline, Week 2,4, and 8

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Treatment Emergent Symptom Scale (TESS)

Time frame:Week 2,4, and 8

descriptive

Secondary/protocol endpoint/low confidence

Rating scale for extrapyramidal side effects (RSESE)

Time frame:baseline, Week 2,4, and 8

descriptive

Secondary/protocol endpoint/low confidence

Abnormal Involuntary Movement Scale (AIMS)

Time frame:baseline, Week 2,4, and 8

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.