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TerminatedPhase 2

A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Asset

PRX-03140

Listed sites

38

Recruiting sites

-

Enrollment

420

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-22•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•Alzheimer's Disease Assessment Scale-Cognitive subscale

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

NCT IDNCT00672945
Org study IDProtocol 01340-202

Timeline

Milestones

Study start2008-04 (month precision)
Study first posted2008-05-06estimated
Last update posted2009-07-30estimated
Primary completion2010-01estimated (month precision)

Assets

Drug assets

PRX-03140

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•Men or Women with a clinical diagnosis of Probable AD
•MMSE score 12 to 22 inclusive
•Age >50 and <90 years
•Received at least 4 months of a stable dose of donepezil 10mg QD for AD
•Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 months
•Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
•No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
•No diagnosis of vascular dementia
•No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for >6 months may be eligible
•No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
•No cognitive rehabilitation within 6 months of the study
•Subject has a regular caregiver willing to attend all study visits
•Signed informed consent by the subject (and legal guardian, if applicable)
•No history of drug or alcohol abuse
•No clinically significant laboratory abnormalities or medical history
•No investigational drug within 30 days of Randomization
•Cannot receive memantine within 2 months of enrollment
•No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment
•No clinically significant ECG abnormalities or cardiac history
•No history of uncontrolled seizure disorder within 12 months of enrollment
•Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
•No history of malignancy within 3 years of randomization
•Women cannot be pregnant or breastfeeding

Endpoints (1)

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.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale-Cognitive subscale.

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.