Alzheimer's DiseasePhase 2NCT00384423
Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
A Phase 2 study testing PRX-03140 in people with Alzheimer's Disease, run by Epix Pharmaceuticals, Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PRX-03140
- How many people
- 80 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Research Center for Clinical Studies
Darien, Connecticut, 06820
Neurology Specialists
Dayton, Ohio, 45408
Alliance for Neuro Research, LLC
Greenville, South Carolina, 29615
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137
California Clinical Trials Medical Group, Inc
Paramount, California, 90723
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, 01201
Berma Research
Plantation, Florida, 33317
Southwest CLinical Research
Rancho Mirage, California, 94109
Pacific Research Network, Inc
San Diego, California, 92103
San Francisco Clinical Research Center
San Francisco, California, 94109
J. Gary Booker, MD
Shreveport, Louisiana, 71104
Comprehensive NeuroScience, Inc
St. Petersburg, Florida, 33702
Meridien Research
St. Petersburg, Florida, 33709
Torrance Clinical Research
Torrance, California, 90505
Saint Johns Office Building
Tulsa, Oklahoma, 74104
About this study
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.
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.
- Conditions
- Alzheimer's Disease
- Being tested
- PRX-03140
- Keywords
- Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-03140Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384423
- Sponsor's protocol ID
- PRX-CP-018
- Status last verified
- Jan 2008
- First submitted
- 4 Oct 2006
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00384423
- Acronym / sponsor ID
- PRX-CP-018
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Epix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-03140 | Drug | – |
Primary outcome
Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Electroencephalogram (EEG) changes through 14 days of treatment.
2 secondary outcomes
Changes in cognition after 2 weeks of treatment.
Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRX-03140 in people with Alzheimer's Disease, run by Epix Pharmaceuticals, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of PRX-03140 during 2 weeks of treatment.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.