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 a year of dosing with MPC-7869.

Condition	Treatment or Intervention	Phase
Alzheimer Disease Dementia	Drug: MPC-7869	Phase III

Further Study Details: 

Primary Outcomes: Cognition and activities of daily living
Secondary Outcomes: Global function and behavior
Expected Total Enrollment:  750

This trial is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group study comparing the safety and efficacy of 2 daily dose levels of MPC-7869 to placebo. The study subjects will have the diagnosis of mild to moderate 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.

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

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.

Teri Calloway       teri.callaway@austin.ppdi.com
Mary L Jackson, RN       mjackson@myriad.com

Alabama
      Alabaster,  Alabama,  35007,  United States; Not yet recruiting
      Huntsville,  Alabama,  35801,  United States; Not yet recruiting
Arizona
      Tucson,  Arizona,  85741-3537,  United States; Not yet recruiting
Arkansas
      Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
California
      Fresno,  California,  93720,  United States; Recruiting
      Lafayette,  California,  94549,  United States; Recruiting
      Laguna Hills,  California,  92653,  United States; Not yet recruiting
      Riverside,  California,  92506,  United States; Not yet recruiting
      Newport Beach,  California,  92660,  United States; Not yet recruiting
      Long Beach,  California,  90822,  United States; Not yet recruiting
      Sacramento,  California,  95816,  United States; Not yet recruiting
      Irvine,  California,  92697-4540,  United States; Not yet recruiting
      Los Angeles,  California,  90033,  United States; Not yet recruiting
      Newport Beach,  California,  92663,  United States; Not yet recruiting
Colorado
      Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Danbury,  Connecticut,  06810,  United States; Not yet recruiting
Delaware
      Wilmington,  Delaware,  19806,  United States; Not yet recruiting
Florida
      Clearwater,  Florida,  33761-2010,  United States; Recruiting
      Orlando,  Florida,  32806,  United States; Recruiting
      Boca Raton,  Florida,  33486,  United States; Recruiting
      Fort Myers,  Florida,  33916,  United States; Recruiting
      West Palm Beach,  Florida,  33407,  United States; Recruiting
      Bay Harbor,  Florida,  33154,  United States; Recruiting
      Hollywood,  Florida,  33021,  United States; Recruiting
      Plantation,  Florida,  33324,  United States; Recruiting
      Tampa,  Florida,  33613,  United States; Recruiting
      Tampa,  Florida,  33609,  United States; Recruiting
      North Miami,  Florida,  33161,  United States; Recruiting
      Ft. Lauderdale,  Florida,  33321,  United States; Recruiting
      Hialeah,  Florida,  33016,  United States; Not yet recruiting
      Ocala,  Florida,  34471,  United States; Not yet recruiting
      Miami,  Florida,  33144,  United States; Not yet recruiting
      Jacksonville,  Florida,  32216,  United States; Not yet recruiting
      Naples,  Florida,  34102,  United States; Not yet recruiting
      Jacksonville,  Florida,  32224,  United States; Not yet recruiting
      Tampa,  Florida,  33617,  United States; Not yet recruiting
      Derrfield Beach,  Florida,  33064,  United States; Not yet recruiting
Georgia
      Atlanta,  Georgia,  30328,  United States; Recruiting
Illinois
      Hoffman Estates,  Illinois,  60194,  United States; Not yet recruiting
Louisiana
      New Orleans,  Louisiana,  70112,  United States; Not yet recruiting
Maryland
      Baltimore,  Maryland,  21285,  United States; Recruiting
Massachusetts
      West Yarmouth,  Massachusetts,  02673,  United States; Recruiting
      Boston,  Massachusetts,  02135,  United States; Not yet recruiting
      Brockton,  Massachusetts,  02301,  United States; Not yet recruiting
      Boston,  Massachusetts,  02118,  United States; Not yet recruiting
Michigan
      Grand Rapids,  Michigan,  49525,  United States; Recruiting
Missouri
      Kansas City,  Missouri,  64114,  United States; Recruiting
      St. Louis,  Missouri,  63141,  United States; Not yet recruiting
New Hampshire
      Lebanon,  New Hampshire,  03756,  United States; Not yet recruiting
New Jersey
      Princeton,  New Jersey,  08540,  United States; Recruiting
      Toms River,  New Jersey,  08755,  United States; Recruiting
      Morristown,  New Jersey,  07960,  United States; Recruiting
      Kenilworth,  New Jersey,  07033,  United States; Recruiting
      Stratford,  New Jersey,  08084,  United States; Not yet recruiting
      Piscataway,  New Jersey,  08855,  United States; Not yet recruiting
New Mexico
      Albuquerque,  New Mexico,  87102,  United States; Not yet recruiting
New York
      Syracuse,  New York,  13210,  United States; Recruiting
      Brooklyn,  New York,  11223,  United States; Not yet recruiting
      Albany,  New York,  12205,  United States; Not yet recruiting
      Elmsford,  New York,  10523,  United States; Not yet recruiting
      New York,  New York,  10032,  United States; Not yet recruiting
      Rochester,  New York,  14620,  United States; Not yet recruiting
North Carolina
      Raleigh,  North Carolina,  27607-6520,  United States; Not yet recruiting
      Durham,  North Carolina,  27710,  United States; Not yet recruiting
Ohio
      Toledo,  Ohio,  43614,  United States; Not yet recruiting
      Columbus,  Ohio,  43210,  United States; Not yet recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  73118,  United States; Recruiting
      Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
      Oklahoma City,  Oklahoma,  73112,  United States; Not yet recruiting
Oregon
      Eugene,  Oregon,  97401,  United States; Not yet recruiting
      Portland,  Oregon,  97210,  United States; Not yet recruiting
      Portland,  Oregon,  97239,  United States; Not yet recruiting
Pennsylvania
      Bala Cynwyd,  Pennsylvania,  19004,  United States; Recruiting
      Scotland,  Pennsylvania,  17254,  United States; Recruiting
      Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19115,  United States; Not yet recruiting
      Pittsburgh,  Pennsylvania,  15213,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
Rhode Island
      East Providence,  Rhode Island,  02914,  United States; Recruiting
      East Providence,  Rhode Island,  02916,  United States; Not yet recruiting
      Providence,  Rhode Island,  02906,  United States; Not yet recruiting
South Carolina
      Greer,  South Carolina,  29651,  United States; Not yet recruiting
      North Charleston,  South Carolina,  29406-6076,  United States; Not yet recruiting
Tennessee
      Johnson City,  Tennessee,  37601,  United States; Recruiting
      Nashville,  Tennessee,  37203,  United States; Recruiting
      Memphis,  Tennessee,  38105,  United States; Not yet recruiting
Texas
      Wichita Falls,  Texas,  76301,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
      Dallas,  Texas,  75231,  United States; Not yet recruiting
      Houston,  Texas,  77030,  United States; Not yet recruiting
      San Antonio,  Texas,  78229,  United States; Not yet recruiting
      Galveston,  Texas,  77555-0539,  United States; Not yet recruiting
Utah
      Salt Lake City,  Utah,  84121,  United States; Not yet recruiting
      Ogden,  Utah,  84405,  United States; Not yet recruiting
Virginia
      Alexandria,  Virginia,  22304,  United States; Not yet recruiting
      Charlottesville,  Virginia,  22903,  United States; Not yet recruiting
Washington
      Bellevue,  Washington,  98004,  United States; Not yet recruiting
      Seattle,  Washington,  98126,  United States; Not yet recruiting
Wisconsin
      Middleton,  Wisconsin,  53562,  United States; Not yet recruiting

Study ID Numbers:  MPC-7869-04-005.02
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  March 15, 2005
ClinicalTrials.gov Identifier:  NCT00105547
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08