Clinical trial NCT00322036: Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Official title: Phase 3 Multinational, 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: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Dementia
Keywords: Alzheimer Disease
Dementia
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 800
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: This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.


Eligibility criteria: Inclusion Criteria:

1. Have had a diagnosis of probable Alzheimer's disease
2. Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
4. Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
5. At least 6 years of education, or sufficient work history to exclude mental retardation.
6. Female subjects must be surgically sterile or postmenopausal for \> 1 year.
7. Adequate vision and hearing to participate in study assessments.
8. Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria:

1. Current evidence of other causes of dementia.. .
2. History of, 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.
3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
4. Major surgery and related complications not resolved within 12 weeks prior to Day 1.
5. Previous participation in an MPC-7869 clinical study.

Primary outcomes:
measure: Cognition and activities of daily living
timeFrame: 18 mos
Secondary outcomes:
measure: Global function and cognition
timeFrame: 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Deerfield Beach
country: United States
state: Florida
city: DelRay Beach
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Farmington Hills
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Edegem
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Sint-truiden
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Medicine Hat
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: Saint John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Verdun
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Odense C
country: Denmark
city: Odense
country: Denmark
city: Bordeaux
country: France
city: Dijon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Reims
country: France
city: Rennes
country: France
city: Saint Herblain
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Darmstadt
country: Germany
city: Dusseldorf
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Mannheim
country: Germany
city: Munchen
country: Germany
city: Schwerin
country: Germany
city: Brescia
country: Italy
city: Milano
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Amsterdam
country: Netherlands
city: Blaricum
country: Netherlands
city: Hertogenbosch
country: Netherlands
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Getafe. Madrid
country: Spain
city: Madrid
country: Spain
city: Lund
country: Sweden
city: Basel
country: Switzerland
city: Bath
country: United Kingdom
state: England
city: London
country: United Kingdom
state: England
city: Oxford
country: United Kingdom
state: England
city: Sheffield
country: United Kingdom
state: England
city: Swindon
country: United Kingdom
state: England
city: Belfast
country: United Kingdom
state: N. Ireland
city: Glasgow
country: United Kingdom
state: Scotland
city: Penarth
country: United Kingdom
state: Wales
city: Southhampton
country: United Kingdom
Study officials:
affiliation: Myrexis Inc.
name: Mark Laughlin, MD
role: STUDY_DIRECTOR
References: