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

Sponsor

Myrexis Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00105547

Collaborator

(none)

1,600

Enrollment

133

Locations

Arms

38.9

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2005

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

800 mg BID

Drug: MPC-7869

oral 800 mg BID

Placebo Comparator: 2

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 behavior [18 mos]

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 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Alabaster	Alabama	United States	35007
2	Huntsville	Alabama	United States	35801
3	Mesa	Arizona	United States	85210
4	Peoria	Arizona	United States	85381
5	Phoenix	Arizona	United States	85013
6	Sun City	Arizona	United States	85351
7	Tucson	Arizona	United States	85741-3537
8	Little Rock	Arkansas	United States	72205
9	Fresno	California	United States	93720
10	Irvine	California	United States	92697-4540
11	La Jolla	California	United States	90237
12	Lafayette	California	United States	94549
13	Laguna Hills	California	United States	92653
14	Long Beach	California	United States	90822
15	Los Angeles	California	United States	90033
16	Newport Beach	California	United States	92660
17	Newport Beach	California	United States	92663
18	Oceanside	California	United States	92056
19	Rancho Mirage	California	United States	92270
20	Sacramento	California	United States	95816
21	San Diego	California	United States	92103
22	San Francisco	California	United States	94109
23	San Francisco	California	United States	94143
24	Vista	California	United States	92083
25	Denver	Colorado	United States	80218
26	Danbury	Connecticut	United States	06810
27	Darien	Connecticut	United States	06820
28	New Haven	Connecticut	United States	06510
29	Washington	District of Columbia	United States	20007
30	Bay Harbor	Florida	United States	33154
31	Boca Raton	Florida	United States	33486
32	Clearwater	Florida	United States	33761-2010
33	Derrfield Beach	Florida	United States	33064
34	Fort Myers	Florida	United States	33916
35	Ft. Lauderdale	Florida	United States	33321
36	Ft. Myers	Florida	United States	33912
37	Hialeah	Florida	United States	33016
38	Hollywood	Florida	United States	33021
39	Jacksonville	Florida	United States	32216
40	Jacksonville	Florida	United States	32224
41	Miami	Florida	United States	33144
42	Naples	Florida	United States	34102
43	North Miami	Florida	United States	33161
44	Ocala	Florida	United States	34471
45	Orlando	Florida	United States	32806
46	Plantation	Florida	United States	33324
47	Pompano Beach	Florida	United States	33060
48	Tampa	Florida	United States	33609
49	Tampa	Florida	United States	33613
50	Tampa	Florida	United States	33617
51	Tampa	Florida	United States	33647
52	West Palm Beach	Florida	United States	33407
53	Atlanta	Georgia	United States	30328
54	Decatur	Georgia	United States	30033
55	Chicago	Illinois	United States	60194
56	Ft. Wayne	Indiana	United States	46805
57	Indianapolis	Indiana	United States	46260
58	Lexington	Kentucky	United States	40504
59	New Orleans	Louisiana	United States	70112
60	Baltimore,	Maryland	United States	21285
61	Glen Burnie	Maryland	United States	21061
62	Boston	Massachusetts	United States	02118
63	Brockton	Massachusetts	United States	02301
64	West Yarmouth	Massachusetts	United States	02673
65	Farmington Hills	Michigan	United States	48334
66	Grand Rapids	Michigan	United States	49525
67	Rochester	Minnesota	United States	55901
68	Kansas City	Missouri	United States	64114
69	St. Louis	Missouri	United States	63141
70	Lebanon	New Hampshire	United States	03756
71	Kenilworth	New Jersey	United States	07033
72	Morristown	New Jersey	United States	07960
73	Piscataway	New Jersey	United States	08855
74	Princeton	New Jersey	United States	08540
75	Stratford	New Jersey	United States	08084
76	Toms River	New Jersey	United States	08755
77	Albuquerque	New Mexico	United States	87102
78	Albany	New York	United States	12205
79	Brooklyn	New York	United States	11201
80	Brooklyn	New York	United States	11223
81	Elmsford	New York	United States	10523
82	New York	New York	United States	10016
83	New York	New York	United States	10021
84	New York	New York	United States	10032
85	Olean	New York	United States	14760
86	Rochester	New York	United States	14620
87	Syracuse	New York	United States	13210
88	Durham	North Carolina	United States	27710
89	Raleigh	North Carolina	United States	27607-6520
90	Winston-Salem	North Carolina	United States	27103
91	Centerville	Ohio	United States	45459
92	Cincinnati	Ohio	United States	45267
93	Columbus	Ohio	United States	43210
94	Toledo	Ohio	United States	43614
95	Oklahoma City	Oklahoma	United States	73112
96	Oklahoma City	Oklahoma	United States	73118
97	Oklahoma City	Oklahoma	United States	73120
98	Eugene	Oregon	United States	97404
99	Portland	Oregon	United States	97210
100	Portland	Oregon	United States	97239
101	Bala Cynwyd	Pennsylvania	United States	19004
102	Jenkintown	Pennsylvania	United States	19046
103	Philadelphia	Pennsylvania	United States	19104
104	Philadelphia	Pennsylvania	United States	19107
105	Philadelphia	Pennsylvania	United States	19115
106	Pittsburgh	Pennsylvania	United States	15206
107	Pittsburgh	Pennsylvania	United States	15213
108	Pittsburg	Pennsylvania	United States	15213
109	Scotland	Pennsylvania	United States	17254
110	East Providence	Rhode Island	United States	02914
111	East Providence	Rhode Island	United States	02916
112	Providence	Rhode Island	United States	02906
113	Beaufort	South Carolina	United States	29902
114	Greer	South Carolina	United States	29651
115	North Charleston	South Carolina	United States	29406-6076
116	Johnson City	Tennessee	United States	37601
117	Memphis	Tennessee	United States	38105
118	Nashville	Tennessee	United States	37203
119	Austin	Texas	United States	78757
120	Dallas	Texas	United States	75390
121	Galveston	Texas	United States	77555-0539
122	Houston	Texas	United States	77030
123	San Antonio	Texas	United States	78229
124	Wichita Falls	Texas	United States	76301
125	Ogden	Utah	United States	84405
126	Salt Lake City	Utah	United States	84107
127	Salt Lake City	Utah	United States	84108
128	Bennington	Vermont	United States	05201
129	Alexandria	Virginia	United States	22304
130	Charlottesville	Virginia	United States	22903
131	Virginia Beach	Virginia	United States	23452
132	Middleton	Wisconsin	United States	53562
133	Milwaukee	Wisconsin	United States	53226