Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
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.
1 other identifier
interventional
80
1 country
17
Brief Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 4, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedJanuary 30, 2008
January 1, 2008
1 year
October 4, 2006
January 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Electroencephalogram (EEG) changes through 14 days of treatment.
Secondary Outcomes (2)
Changes in cognition after 2 weeks of treatment.
Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
California Clinical Trials Medical Group, Inc
Paramount, California, 90723, United States
Southwest CLinical Research
Rancho Mirage, California, 94109, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Research Center for Clinical Studies
Darien, Connecticut, 06820, United States
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137, United States
Berma Research
Plantation, Florida, 33317, United States
Comprehensive NeuroScience, Inc
St. Petersburg, Florida, 33702, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
J. Gary Booker, MD
Shreveport, Louisiana, 71104, United States
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, 01201, United States
Neurology Specialists
Dayton, Ohio, 45408, United States
Saint Johns Office Building
Tulsa, Oklahoma, 74104, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Alliance for Neuro Research, LLC
Greenville, South Carolina, 29615, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2006
First Posted
October 6, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2007
Last Updated
January 30, 2008
Record last verified: 2008-01