Clinical trial NCT00380276: Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol
Official title: Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
Dementia
Dementia of Alzheimer Type
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label treatment with MPC-7869 for participants in a previous randomized study.


Eligibility criteria: Inclusion Criteria:

* Participation in a previous MPC-7869 randomized protocol
* 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.
* Female subjects must be surgically sterile or postmenopausal for \> 1 year.
* Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary Safety
timeFrame: For study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: Irvine
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: 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: Vista
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Darien
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Washington D.C
country: United States
state: District of Columbia
city: Deerfield Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ft Meyers
country: United States
state: Florida
city: Hollywood
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: Sunrise
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: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: West Yarmouth
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
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: Princeton
country: United States
state: New Jersey
city: Stratford
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: Elmsford
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: Centerville
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: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
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: Beaufort
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ogden
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
city: Winnepeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Regina
country: Canada
state: Saskatchewan
Study officials:
affiliation: Myrexis Inc.
name: Mark Laughlin, MD
role: STUDY_DIRECTOR
References: