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TerminatedPhase 3

Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Asset

bifeprunox

Listed sites

51

Recruiting sites

-

Enrollment

60

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Brief Psychiatric Rating Scale (BPRS) Total Score

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

Secondary2005-003475-20
NCT IDNCT00160147
Org study IDS154.3.016

Timeline

Milestones

Study first posted2005-09-12estimated
Study start2005-12 (month precision)
Primary completion2008-01actual (month precision)
Study completion2008-01actual (month precision)
Last update posted2015-02-09estimated

Assets

Drug assets

bifeprunox

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of dementia of the Alzheimer's type

Exclusion criteria

•History of seizure disorder
•Clinically significant electrocardiogram (ECG)
•Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma

Endpoints (2)

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
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events

Time frame:10 weeks

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Brief Psychiatric Rating Scale (BPRS) Total Score

Time frame:10 weeks

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.