Efficacy Study of MPC-7869 to Treat Patients With Alzheim... | NCT00105547

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Mar 15, 2005

First Submission Date that Met QC Criteria

Mar 15, 2005

First Posted Date

Mar 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2009

Last Update Posted Date

May 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	800 mg BID	Drug: MPC-7869
2	Placebo Comparator	BID dosing	Drug: MPC-7869

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MPC-7869	Drug	oral 800 mg BID	1
MPC-7869

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

Measure	Description	Time Frame
Global function and behavior		18 mos

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ed Swabb, MD	Myrexis Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Alabaster	Alabama	35007	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20009055	Derived	Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH; Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. JAMA. 2009 Dec 16;302(23):2557-64. doi: 10.1001/jama.2009.1866.

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders