Clinical trial NCT00384423: Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
AD
PRX-03140
Dementia
Epix
Predix
Cognition enhancing
Lead sponsor: Epix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety and tolerability of PRX-03140 during 2 weeks of treatment.
measure: Electroencephalogram (EEG) changes through 14 days of treatment.
Secondary outcomes:
measure: Changes in cognition after 2 weeks of treatment.
measure: Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
Other outcomes:
Locations:
city: Paramount
country: United States
facility: California Clinical Trials Medical Group, Inc
state: California
city: Rancho Mirage
country: United States
facility: Southwest CLinical Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Darien
country: United States
facility: Research Center for Clinical Studies
state: Connecticut
city: Miami
country: United States
facility: Miami Jewish Home and Hospital for the Aged
state: Florida
city: Plantation
country: United States
facility: Berma Research
state: Florida
city: St Petersburg
country: United States
facility: Meridien Research
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Shreveport
country: United States
facility: J. Gary Booker, MD
state: Louisiana
city: Pittsfield
country: United States
facility: Neuroscience Research of the Berkshires
state: Massachusetts
city: Dayton
country: United States
facility: Neurology Specialists
state: Ohio
city: Tulsa
country: United States
facility: Saint Johns Office Building
state: Oklahoma
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Alliance for Neuro Research, LLC
state: South Carolina
Study officials:
References: