CompletedPhase 2

Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.

Lead sponsor

Epix Pharmaceuticals, Inc.

Asset

PRX-03140

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Safety and tolerability of PRX-03140•Electroencephalogram (EEG) changes

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 IDNCT00384423

Org study IDPRX-CP-018

Timeline

Milestones

Study start2006-10 (month precision)

Study first posted2006-10-06estimated

Primary completion2007-10actual (month precision)

Last update posted2008-01-30estimated

Assets

Drug assets

PRX-03140

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•At least 60 years old.

•On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.

•Diagnosis of probable Alzheimer's Disease.

•Mild dementia.

•You or your authorized representative provide voluntary written informed consent.

•Not pregnant, planning a pregnancy, or capable of becoming pregnant

Exclusion criteria

•Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.

•Intolerance to Aricept.

•Dementia other than Alzheimer's type.

•Parkinson's Disease.

•History of seizure or epilepsy.

•History of stroke.

•Participation in another research study within last 30 days.

•Enrollment in any previous research study testing PRX-03140.

•Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.

•Use of tobacco products within last 4 weeks.

•Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.

•Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.

•Major surgery within last 4 weeks.

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)

Fluid / digital biomarkers

Safety / tolerability / PK

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

Electroencephalogram (EEG) changes through 14 days of treatment.

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety and tolerability of PRX-03140 during 2 weeks of treatment.

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Changes in cognition after 2 weeks of treatment.

descriptive

Secondary/protocol endpoint/low confidence

Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

concentration, 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.