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

Sponsor

Myrexis Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00322036

Collaborator

(none)

800

Enrollment

Locations

Arms

Duration (Months)

8.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia	Drug: MPC-7869 Drug: MPC-7869	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2006

Anticipated Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral 800 mg BID dosing	Drug: MPC-7869 Oral 800 mg BID
Placebo Comparator: 2 Oral BID dosing	Drug: MPC-7869 Oral BID dosing

Arm

Intervention/Treatment

Experimental: 1

Oral 800 mg BID dosing

Drug: MPC-7869

Oral 800 mg BID

Placebo Comparator: 2

Oral BID dosing

Drug: MPC-7869

Oral BID dosing

Outcome Measures

Primary Outcome Measures

Cognition and activities of daily living [18 mos]

Secondary Outcome Measures

Global function and cognition [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have had a diagnosis of probable Alzheimer's disease
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).
Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
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.
At least 6 years of education, or sufficient work history to exclude mental retardation.
Female subjects must be surgically sterile or postmenopausal for > 1 year.
Adequate vision and hearing to participate in study assessments.
Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria:

Current evidence of other causes of dementia.. .
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.
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.
Previous participation in an MPC-7869 clinical study.

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Tucson	Arizona	United States
3	Costa Mesa	California	United States
4	San Diego	California	United States
5	New Haven	Connecticut	United States
6	Deerfield Beach	Florida	United States
7	DelRay Beach	Florida	United States
8	Gainsville	Florida	United States
9	Hollywood	Florida	United States
10	Miami	Florida	United States
11	Tampa	Florida	United States
12	West Palm Beach	Florida	United States
13	Chicago	Illinois	United States
14	Indianapolis	Indiana	United States
15	Lexington	Kentucky	United States
16	Boston	Massachusetts	United States
17	Farmington Hills	Michigan	United States
18	St. Louis	Missouri	United States
19	Rochester	New York	United States
20	Providence	Rhode Island	United States
21	Charleston	South Carolina	United States
22	Dallas	Texas	United States
23	Salt Lake City	Utah	United States
24	Aalst		Belgium
25	Antwerpen		Belgium
26	Edegem		Belgium
27	Hasselt		Belgium
28	Leuven		Belgium
29	Sint-truiden		Belgium
30	Calgary	Alberta	Canada
31	Medicine Hat	Alberta	Canada
32	Vancouver	British Columbia	Canada
33	Winnipeg	Manitoba	Canada
34	Moncton	New Brunswick	Canada
35	Saint John	New Brunswick	Canada
36	Halifax	Nova Scotia	Canada
37	Kingston	Ontario	Canada
38	London	Ontario	Canada
39	Ottawa	Ontario	Canada
40	Peterborough	Ontario	Canada
41	Toronto	Ontario	Canada
42	Greenfield Park	Quebec	Canada
43	Montreal	Quebec	Canada
44	Verdun	Quebec	Canada
45	Regina	Saskatchewan	Canada
46	Odense C		Denmark
47	Odense		Denmark
48	Bordeaux		France
49	Dijon		France
50	Marseille		France
51	Montpellier		France
52	Nice		France
53	Reims		France
54	Rennes		France
55	Saint Herblain		France
56	Toulouse		France
57	Tours		France
58	Berlin		Germany
59	Bochum		Germany
60	Bonn		Germany
61	Darmstadt		Germany
62	Dusseldorf		Germany
63	Freiburg		Germany
64	Hamburg		Germany
65	Heidelberg		Germany
66	Leipzig		Germany
67	Mannheim		Germany
68	Munchen		Germany
69	Schwerin		Germany
70	Brescia		Italy
71	Milano		Italy
72	Perugia		Italy
73	Pisa		Italy
74	Roma		Italy
75	Amsterdam		Netherlands
76	Blaricum		Netherlands
77	Hertogenbosch		Netherlands
78	Barcelona		Spain
79	Bilbao		Spain
80	Getafe. Madrid		Spain
81	Madrid		Spain
82	Lund		Sweden
83	Basel		Switzerland
84	Bath	England	United Kingdom
85	London	England	United Kingdom
86	Oxford	England	United Kingdom
87	Sheffield	England	United Kingdom
88	Swindon	England	United Kingdom
89	Belfast	N. Ireland	United Kingdom
90	Glasgow	Scotland	United Kingdom
91	Penarth	Wales	United Kingdom
92	Southhampton		United Kingdom