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

Epix Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: PRX-03140

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384423

PRX-CP-018

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No 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.