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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: PRX-03140


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRX-03140|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of PRX-03140 during 2 weeks of treatment. |  |  | 
| Electroencephalogram (EEG) changes through 14 days of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognition after 2 weeks of treatment. |  |  | 
| Blood concentrations of PRX-03140 and Aricept during 14 days of treatment. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing