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:
Myrexis Inc.
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00322036
First received: May 2, 2006
Last updated: August 1, 2008
Last verified: August 2008
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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:
- Have had a diagnosis of probable Alzheimer's disease
- 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).
- Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
- 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.
- At least 6 years of education, or sufficient work history to exclude mental retardation.
- Female subjects must be surgically sterile or postmenopausal for > 1 year.
- Adequate vision and hearing to participate in study assessments.
- Subjects must have a reliable caregiver who can read, understand and speak same language.
Exclusion Criteria:
- Current evidence of other causes of dementia.. .
- 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.
- 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.
- 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
Show 92 Study LocationsSponsors 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 May 23, 2013