TerminatedPhase 2

Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease

Lead sponsor

Epix Pharmaceuticals, Inc.

Assets

Donepezil / PRX-03140

Listed sites

Recruiting sites

Enrollment

236

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-24•Study partner/caregiver required

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 IDNCT00693004

Org study IDProtocol 03140-203

Timeline

Milestones

Study start2008-05 (month precision)

Study first posted2008-06-06estimated

Last update posted2009-07-30estimated

Primary completion2010-01estimated (month precision)

Assets

Drug assets

Donepezil 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

Inclusion criteria

•Men or Women with a clinical diagnosis of Probable AD

•MMSE score 16 to 24 inclusive

•Age >50 and <90 years

•Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 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)

Exclusion criteria

•No history of drug or alcohol abuse

•No clinically significant laboratory abnormalities or medical history

•No investigational drug within 30 days of Randomization

•Intolerance or allergy to cholinesterase inhibitors

•Cannot have been on cholinesterase inhibitors for AD for > 2 years

•If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization

•Cannot have received memantine within 2 months

•No clinically significant ECG abnormalities prior to randomization

•No history of uncontrolled seizure disorder within 12 months

•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.