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

Study Overview
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Brief Summary
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A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: PRX-03140
* Drug: Donepezil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: PRX-03140<br> | Drug: PRX-03140<br> <br> |
| Active Comparator: donepezil<br> | Drug: Donepezil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-Cognitive subscale. |  |  |