A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil
This study has been terminated.
Information provided by:
Epix Pharmaceuticals, Inc.
First received: May 2, 2008
Last updated: July 28, 2009
Last verified: July 2009
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.
||Primary Purpose: Treatment
||Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil
Primary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cognitive subscale.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
|Ages Eligible for Study:
||50 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672945
Epix Pharmaceuticals, Inc.
No publications provided
||Elkan R. Gamzu, PhD, EPIX Pharmaceuticals, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2008
||July 28, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Agents