AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT00672945

A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

A Phase 2 study testing PRX-03140 in people with Alzheimer's Disease, run by Epix Pharmaceuticals, Inc. at 38 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
PRX-03140
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
38 sitesUnited States
Study dates
Apr 2008to Jan 2010
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Neurological Associates of Albany, P.C.

    Albany, New York, 12208

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Social Psychiatry Research Institute

    Brooklyn, New York, 11235

  • University of Vermont

    Burlington, Vermont, 05401

  • The Neurological Institute, P.A.

    Charlotte, North Carolina, 28204

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • RI Mood and Memory Research Institute

    East Providence, Rhode Island, 02914

  • Alexian Brothers Neroscience Institute

    Elk Grove Village, Illinois, 60007

  • Todd Swick, MD, PA

    Houston, Texas, 77063

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Memory Center of America

    Long Beach, New Jersey, 07740

  • MedArk

    Morgantown, North Carolina, 28655

  • Synergy Clinical Research Center

    National City, California, 91950

  • The Mount Sinai Medical Center

    New York, New York, 10029

  • The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • The ICPS Group

    Norwood, Massachusetts, 02062

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Compass Research

    Orlando, Florida, 32806

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • PsyPharma Clinical Research, Inc.

    Phoenix, Arizona, 85050

  • Berma Research Group

    Plantation, Florida, 33317

  • Global Medical Institutes

    Princeton, New Jersey, 08540

  • Maine Neurology

    Scarborough, Maine, 04074

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • J. Gary Booker, MD

    Shreveport, Louisiana, 71104

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Behavioral Medical Research of Staten Island

    Staten Island, New York, 10305

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Roskamp Institute

    Tampa, Florida, 33617

  • Neurology and Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Torrance Clinical Research

    Torrance, California, 90505

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona, 85741

  • Tulsa Clinical Research, LLC

    Tulsa, Oklahoma, 74104

  • The Center for Excellence in Aging and Geriatric Health

    Williamsburg, Virginia, 23185

Other trials in United States

About this study

Official title: Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

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.

Being tested
PRX-03140, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRX-03140Drug

  • PlaceboDrug

Study groups in NCT00672945
Study groupRoleWhat they receive
PRX-03140ExperimentalNot described
Receives: Drug: PRX-03140
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease Assessment Scale-Cognitive subscale.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2010 (estimated)

Resources

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
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672945
Sponsor's protocol ID
Protocol 01340-202
Status last verified
Jul 2009
First submitted
2 May 2008
Last updated
30 Jul 2009
Results posted
No

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 38 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?

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: stopped early, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.

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?

Alzheimer's Disease Assessment Scale-Cognitive subscale.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672945.

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 Jul 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in