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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Alzheimer Disease, Dementia

Intervention / Treatment
-----------------
* Drug: MPC-7869
* Drug: MPC-7869


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>800 mg BID | Drug: MPC-7869<br>* oral 800 mg BID<br>|
| Placebo Comparator: 2<br>BID dosing | Drug: MPC-7869<br>* Oral BID dosing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition and activities of daily living |  | 18 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global function and behavior |  | 18 mos | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's, Dementia, Dementia of Alzheimer Type