Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

Alzheimer's Disease Clinical Trial

Official title:

Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00380276
• Other study ID #: MPC-7869-05-009
• Status: Terminated
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: August 1, 2008
• Start date: September 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2008
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open-label treatment with MPC-7869 for participants in a previous randomized study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Participation in a previous MPC-7869 randomized protocol

• 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.

• Female subjects must be surgically sterile or postmenopausal for > 1 year.

• Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MPC-7869
800 mg BID Oral dosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety		For study duration	Yes