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

This study has been completed.
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00105547
First received: March 15, 2005
Last updated: May 3, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Dementia
Drug: MPC-7869
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Cognition and activities of daily living [ Time Frame: 18 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global function and behavior [ Time Frame: 18 mos ] [ Designated as safety issue: No ]

Enrollment: 1600
Study Start Date: February 2005
Study Completion Date: May 2008
Arms Assigned Interventions
Experimental: 1
800 mg BID
Drug: MPC-7869
oral 800 mg BID
Placebo Comparator: 2
BID dosing
Drug: MPC-7869
Oral BID 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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105547

  Show 133 Study Locations
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Ed Swabb, MD Myrexis Inc.
  More Information

No publications provided by Myrexis Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00105547     History of Changes
Other Study ID Numbers: MPC-7869-04-005.02
Study First Received: March 15, 2005
Last Updated: May 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Alzheimer's
Dementia
Dementia of Alzheimer Type

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014