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← Trials/Trial dossier/NCT06875986

Recruiting

REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)

Asset

Brexpiprazole

Listed sites

1

Recruiting sites

1

Enrollment

200

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Safety Information (Adverse Event)•Safety Information (Special Situations)•Safety Information

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 ID331-101-00612
NCT IDNCT06875986

Timeline

Milestones

Study first posted2025-03-14actual
Study start2025-04-17actual
Last update posted2025-07-02actual
Primary completion2027-09-30estimated
Study completion2028-09-23estimated

Assets

Drug assets

Brexpiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age15 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients diagnosed with Alzheimer's disease

Exclusion criteria

Endpoints (5)

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

Safety / tolerability / PK
4
Disease progression
1

Disease progression

1 endpoint
Primary/protocol endpoint

Safety Information (Special Situations)

Time frame:24 weeks from the initiation of brexpiprazole treatment

event count, event

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Safety Information (Adverse Event)

Time frame:24 weeks from the initiation of brexpiprazole treatment

event count, event

Primary/protocol endpoint

Safety Information (Number of off-Label Use)

Time frame:24 weeks from the initiation of brexpiprazole treatment

event count, event

Primary/protocol endpoint

Safety Information (Serious Adverse Event)

Time frame:24 weeks from the initiation of brexpiprazole treatment

event count, event

Primary/protocol endpoint

Safety Information (Non-serious Adverse Events)

Time frame:24 weeks from the initiation of brexpiprazole treatment

event count, event

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.