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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRX-03140
Placebo
Sponsored by
Epix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Barrow Neurological Institute
  • PsyPharma Clinical Research, Inc.
  • Northwest NeuroSpecialists, PLLC
  • Synergy Clinical Research Center
  • Pacific Neuroscience Medical Group
  • California Neuroscience Research Medical Group, Inc.
  • Torrance Clinical Research
  • Bradenton Research Center
  • Brain Matters Research
  • Clinical Neuroscience Solutions, Inc.
  • Renstar Medical Research
  • Compass Research
  • Berma Research Group
  • Meridien Research
  • Stedman Clinical Trials
  • Roskamp Institute
  • Alexian Brothers Neroscience Institute
  • Four Rivers Clinical Research
  • J. Gary Booker, MD
  • Maine Neurology
  • The ICPS Group
  • Memory Center of America
  • Alzheimer's Research Corporation
  • Global Medical Institutes
  • Neurological Associates of Albany, P.C.
  • Social Psychiatry Research Institute
  • The Mount Sinai Medical Center
  • Behavioral Medical Research of Staten Island
  • The Neurological Institute, P.A.
  • MedArk
  • Neurology and Neuroscience Center of Ohio
  • Tulsa Clinical Research, LLC
  • RI Mood and Memory Research Institute
  • Todd Swick, MD, PA
  • The Memory Clinic
  • University of Vermont
  • The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School
  • The Center for Excellence in Aging and Geriatric Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX-03140

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive subscale.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2008
Last Updated
July 28, 2009
Sponsor
Epix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00672945
Brief Title
A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil
Official Title
Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Epix Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRX-03140
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRX-03140
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
PsyPharma Clinical Research, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pacific Neuroscience Medical Group
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Berma Research Group
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Roskamp Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Alexian Brothers Neroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
J. Gary Booker, MD
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Maine Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
The ICPS Group
City
Norwood
State/Province
Massachusetts
ZIP/Postal Code
02062
Country
United States
Facility Name
Memory Center of America
City
Long Beach
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Alzheimer's Research Corporation
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
Global Medical Institutes
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Neurological Associates of Albany, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Behavioral Medical Research of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
The Neurological Institute, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
MedArk
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Neurology and Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
RI Mood and Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Todd Swick, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
The Center for Excellence in Aging and Geriatric Health
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States

12. IPD Sharing Statement

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

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