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Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

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Trial Conditions
  • Alzheimer's Disease
What is the purpose of this trial?

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week double-blind treatment period.

Date & Status


Who can Participate?


50  - 90 



- Men or Women with a clinical diagnosis of Probable AD

- MMSE score 12 to 22 inclusive

- Age >50 and <90 years

- Received at least 4 months of a stable dose of donepezil 10mg QD for AD

- Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 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)

- No history of drug or alcohol abuse

- No clinically significant laboratory abnormalities or medical history

- No investigational drug within 30 days of Randomization

- Cannot receive memantine within 2 months of enrollment

- No other prescription acetylcholinesterase inhibitors for AD (other than donepezil)
within 4 months of enrollment

- No clinically significant ECG abnormalities or cardiac history

- No history of uncontrolled seizure disorder within 12 months of enrollment

- Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine

- No history of malignancy within 3 years of randomization

- Women cannot be pregnant or breastfeeding

Gender: Both
Trial Interventions
  • PRX-03140
  • Placebo
Other Information

Sponsor: Epix Pharmaceuticals, Inc.
Phase: Phase 2
Trial ID: NCT00672945
Volunteers:  Not Accepting Healthy Volunteers

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