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Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MPC-7869
MPC-7869
Sponsored by
Myrexis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's, Dementia, Dementia of Alzheimer Type

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

800 mg BID

BID dosing

Outcomes

Primary Outcome Measures

Cognition and activities of daily living

Secondary Outcome Measures

Global function and behavior

Full Information

First Posted
March 15, 2005
Last Updated
May 3, 2009
Sponsor
Myrexis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00105547
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Myrexis Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Alzheimer's, Dementia, Dementia of Alzheimer Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
800 mg BID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
BID dosing
Intervention Type
Drug
Intervention Name(s)
MPC-7869
Intervention Description
oral 800 mg BID
Intervention Type
Drug
Intervention Name(s)
MPC-7869
Intervention Description
Oral BID dosing
Primary Outcome Measure Information:
Title
Cognition and activities of daily living
Time Frame
18 mos
Secondary Outcome Measure Information:
Title
Global function and behavior
Time Frame
18 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ed Swabb, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
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United States
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741-3537
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4540
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United States
City
La Jolla
State/Province
California
ZIP/Postal Code
90237
Country
United States
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
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United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
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United States
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Los Angeles
State/Province
California
ZIP/Postal Code
90033
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United States
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Newport Beach
State/Province
California
ZIP/Postal Code
92660
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United States
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Newport Beach
State/Province
California
ZIP/Postal Code
92663
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United States
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Oceanside
State/Province
California
ZIP/Postal Code
92056
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United States
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Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
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United States
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Sacramento
State/Province
California
ZIP/Postal Code
95816
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92103
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94109
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94143
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United States
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Vista
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California
ZIP/Postal Code
92083
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United States
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Denver
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Colorado
ZIP/Postal Code
80218
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United States
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Danbury
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Connecticut
ZIP/Postal Code
06810
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United States
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Darien
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Connecticut
ZIP/Postal Code
06820
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United States
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New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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United States
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Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
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United States
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Bay Harbor
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Florida
ZIP/Postal Code
33154
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United States
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Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
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United States
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Clearwater
State/Province
Florida
ZIP/Postal Code
33761-2010
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United States
City
Derrfield Beach
State/Province
Florida
ZIP/Postal Code
33064
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United States
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
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Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
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United States
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Miami
State/Province
Florida
ZIP/Postal Code
33144
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United States
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Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
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North Miami
State/Province
Florida
ZIP/Postal Code
33161
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United States
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Ocala
State/Province
Florida
ZIP/Postal Code
34471
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United States
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
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United States
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
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United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
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United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33647
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60194
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United States
City
Ft. Wayne
State/Province
Indiana
ZIP/Postal Code
46805
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United States
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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United States
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Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
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United States
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
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United States
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Baltimore,
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
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Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
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United States
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West Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
02673
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United States
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Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
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United States
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
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United States
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Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
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United States
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Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
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United States
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
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Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855
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United States
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Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
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United States
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Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
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United States
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Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
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United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
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United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11223
Country
United States
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Scotland
State/Province
Pennsylvania
ZIP/Postal Code
17254
Country
United States
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-6076
Country
United States
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0539
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20009055
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.
Results Reference
derived

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Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's

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