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CompletedPhase 4

Treatment of Behavioral Symptoms in Alzheimer's Disease

Asset

Haloperidol

Listed sites

1

Recruiting sites

-

Enrollment

44

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•For the primary hypothesis, the primary endpoint is time to relapse

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 ID#4051R
NCT IDNCT00009217
NihR01MH055735

Timeline

Milestones

Study start1999-01 (month precision)
Study first posted2001-01-24estimated
Primary completion2004-12actual (month precision)
Study completion2004-12actual (month precision)
Last update posted2016-05-24estimated

Assets

Drug assets

Haloperidol

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Meets DSM-IV criteria for dementia either sex, age 50-95 years
•Meets NINCDS-ADRDA criteria for probable Alzheimer's disease
•Meets Folstein Mini-Mental State Exam score of 5-26, inclusive
•Intellectual impairment reported for at least six months
•Availability of family member who has had direct contact with the patient for an average of at least once every week during the three months prior to study entry
•Has current symptoms of psychosis or agitation. Criteria for "psychosis" requires the presence of delusions and/or hallucinations identified by the Columbia University Scale for Psychopathology in Alzheimer's Disease (CUSPAD) and a minimum Brief Psychiatric Rating Scale (BPRS) psychosis factor score of at least 4 (moderate severity) on one of the following two items: These two items comprise the psychosis factor, excluding the item for conceptual disorganization. Agitation is defined as a score of greater than 3 (present at least 10 days per month) on one or more of the CERAD Behavioral Rating Scale for Dementia items for agitation, purposeless wandering, verbal aggression or physical aggression.
•Free of psychotropic medication for at least two weeks prior to study entry, or able to tolerate medication washout for this period.
•Informed consent by patient and family member, as per IRB procedures at New York State Psychiatric Institute

Exclusion criteria

•Acute unstable medical condition, delirium, alcohol or substance abuse or dependence within the past 1 year
•Clinical evidence of stroke, other dementias including vascular or Lewy body or frontotemporal dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, tardive dyskinesia
•Diagnosis of a psychotic disorder antedating the onset of dementia
•Antipsychotic medication usage during 4 weeks prior to study entry
•Contraindication to the use of haloperidol

Endpoints (4)

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)
2
Global cognition
1
Behavior / neuropsychiatric
1

Global cognition

1 endpoint
Secondary/protocol endpoint

MMSE and Blessed Functional Activity Scale

Time frame:0-20 weeks in Phase A and 0-24 weeks in Phase B

Mini-Mental State Examination (MMSE)

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Severity of Brief Psychiatric Rating Scale psychosis and hostile suspiciousness factor scores

Time frame:0-20 weeks in Phase A and 0-24 weeks in Phase B

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

For the primary hypothesis, the primary endpoint is time to relapse.

Time frame:0-24 weeks in Phase B

time to event, event

Secondary/protocol endpoint/low confidence

Severity of target symptoms at the end of Phase A as a predictor of relapse

Time frame:0-24 weeks in Phase B

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.