Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

This study has been terminated.

( Myriad has discontinued the development of Flurizan. )

First Received: September 21, 2006 Last Updated: August 1, 2008 History of Changes

Sponsor:	Myriad Pharmaceuticals
Information provided by:	Myriad Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00380276

Purpose

Open-label treatment with MPC-7869 for participants in a previous randomized study.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: MPC-7869	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Further study details as provided by Myriad Pharmaceuticals:

Primary Outcome Measures:

Primary Safety [ Time Frame: For study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
Open Label Arm Treatment is open-label	Drug: MPC-7869 800 mg BID Oral dosing

Eligibility

Criteria

Inclusion Criteria:

Participation in a previous MPC-7869 randomized protocol
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.
Female subjects must be surgically sterile or postmenopausal for > 1 year.
Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380276

Sponsors and Collaborators

Myriad Pharmaceuticals

Investigators

Study Director:

Mark Laughlin, MD

Myriad Pharmaceuticals

More Information

No publications provided

Responsible Party:	Myriad Pharmaceuticals ( Ed Swabb, MD )
Study ID Numbers:	MPC-7869-05-009
Study First Received:	September 21, 2006
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00380276 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Myriad Pharmaceuticals:

Alzheimer's
Dementia
Dementia of Alzheimer Type

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 20, 2009