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

Phase 3

Terminated

• Conditions: Alzheimer Disease; Dementia
• Interventions: Drug: MPC-7869

• Registration Number: NCT00322036
• Lead Sponsor: Myrexis Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-04
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-01
• Last Update Posted: 2008-08-05
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MPC-7869	Oral 800 mg BID dosing
2	MPC-7869	Oral BID dosing

Primary Outcome Measures

Name	Time	Method
Cognition and activities of daily living	18 mos

Secondary Outcome Measures

Name	Time	Method
Global function and cognition	18 months