Trial record 2 of 4 for:    flurizan

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

This study has been terminated.
(Myriad has discontinued the development of Flurizan.)
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00322036
First received: May 2, 2006
Last updated: August 1, 2008
Last verified: August 2008
  Purpose

This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Multinational, 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 cognition [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: May 2006
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Experimental: 1
Oral 800 mg BID dosing
Drug: MPC-7869
Oral 800 mg BID
Placebo Comparator: 2
Oral BID dosing
Drug: MPC-7869
Oral BID dosing

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have had a diagnosis of probable Alzheimer's disease
  2. Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
  3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
  4. Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
  5. At least 6 years of education, or sufficient work history to exclude mental retardation.
  6. Female subjects must be surgically sterile or postmenopausal for > 1 year.
  7. Adequate vision and hearing to participate in study assessments.
  8. Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria:

  1. Current evidence of other causes of dementia.. .
  2. History of, 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.
  3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
  4. Major surgery and related complications not resolved within 12 weeks prior to Day 1.
  5. Previous participation in an MPC-7869 clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322036

  Show 92 Study Locations
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Mark Laughlin, MD Myrexis Inc.
  More Information

No publications provided

Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00322036     History of Changes
Other Study ID Numbers: MPC-7869-05-010.01
Study First Received: May 2, 2006
Last Updated: August 1, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Myrexis Inc.:
Alzheimer Disease
Dementia

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 April 16, 2014