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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105547
• Other study ID #: MPC-7869-04-005.02
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2005
• Last updated: May 3, 2009
• Start date: February 2005
• Est. completion date: May 2008

Study information

• Verified date: May 2009
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Drug:
• MPC-7869
oral 800 mg BID
• MPC-7869
Oral BID dosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition and activities of daily living		18 mos	No
Secondary	Global function and behavior		18 mos	No