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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384423

Enrollment

Registered

2006-10-06

Start date

2006-10-31

Completion date

Unknown

Last updated

2008-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing

Brief summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.

Interventions

DRUGPRX-03140

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of PRX-03140 during 2 weeks of treatment.	—
Electroencephalogram (EEG) changes through 14 days of treatment.	—

Secondary

Measure	Time frame
Changes in cognition after 2 weeks of treatment.	—
Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026