Clinical trial NCT00105547: Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Official title: Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Dementia
Keywords: Alzheimer's
Dementia
Dementia of Alzheimer Type
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2005-03-16
Enrollment: 1600
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.

Detailed description: This trial is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of MPC-7869 to placebo. The study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.

The primary objective of the study is to evaluate the change in cognition and activities of daily living.

Eligibility criteria: Inclusion Criteria:

* Have had a diagnosis of probable Alzheimer's disease.
* Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
* Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
* Ability to read and understand English or Spanish to ensure compliance with cognitive testing and study visit procedures.
* Female subjects must be surgically sterile or postmenopausal for \> 1 year.
* Subjects currently taking approved medication for Alzheimer's disease for at least six months prior to day 1 may be enrolled.
* Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

* Current evidence of other causes of dementia.
* History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
* Chronic or acute renal, hepatic or metabolic disorder.
* Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
* Major surgery and related complications not resolved within 12 weeks prior to Day 1.

Primary outcomes:
measure: Cognition and activities of daily living
timeFrame: 18 mos
Secondary outcomes:
measure: Global function and behavior
timeFrame: 18 mos
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Lafayette
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Vista
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Darien
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Bay Harbor
country: United States
state: Florida
city: Boca Raton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Derrfield Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ft. Myers
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Ft. Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore,
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: West Yarmouth
country: United States
state: Massachusetts
city: Farmington Hills
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Kenilworth
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Piscataway
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Stratford
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Elmsford
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Olean
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Centerville
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: East Providence
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Beaufort
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: North Charleston
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
city: Alexandria
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Middleton
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Myrexis Inc.
name: Ed Swabb, MD
role: STUDY_DIRECTOR
References:
citation: Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH; Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. JAMA. 2009 Dec 16;302(23):2557-64. doi: 10.1001/jama.2009.1866.