Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
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|ClinicalTrials.gov Identifier: NCT00384423|
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 30, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: PRX-03140||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2007|
- Safety and tolerability of PRX-03140 during 2 weeks of treatment.
- Electroencephalogram (EEG) changes through 14 days of treatment.
- Changes in cognition after 2 weeks of treatment.
- Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
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|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- At least 60 years old.
- On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
- Diagnosis of probable Alzheimer's Disease.
- Mild dementia.
- You or your authorized representative provide voluntary written informed consent.
- Not pregnant, planning a pregnancy, or capable of becoming pregnant.
- Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
- Intolerance to Aricept.
- Dementia other than Alzheimer's type.
- Parkinson's Disease.
- History of seizure or epilepsy.
- History of stroke.
- Participation in another research study within last 30 days.
- Enrollment in any previous research study testing PRX-03140.
- Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
- Use of tobacco products within last 4 weeks.
- Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
- Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
- Major surgery within last 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384423
|Other Study ID Numbers:||
|First Posted:||October 6, 2006 Key Record Dates|
|Last Update Posted:||January 30, 2008|
|Last Verified:||January 2008|
Central Nervous System Diseases
Nervous System Diseases