Status:
TERMINATED
A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil
Lead Sponsor:
Epix Pharmaceuticals, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief Summary
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 trea...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00672945
Start Date
April 1 2008
Last Update
July 30 2009
Active Locations (38)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
PsyPharma Clinical Research, Inc.
Phoenix, Arizona, United States, 85050
3
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741
4
Synergy Clinical Research Center
National City, California, United States, 91950