Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease
This study has been terminated.
Information provided by:
Epix Pharmaceuticals, Inc.
First received: May 30, 2008
Last updated: July 28, 2009
Last verified: July 2009
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.
||Primary Purpose: Treatment
||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
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
Active Comparator: donepezil
|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 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)
- 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
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: NCT00693004
Epix Pharmaceuticals, Inc.
No publications provided
||Elkan R. Gamzu, PhD, EPIX Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 30, 2008
||July 28, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 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