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 - ND

• Conditions: Treatment of mild Alzheimer s disease.; MedDRA version: 6.1Level: PTClassification code 10012271

• Registration Number: EUCTR2006-000654-43-IT
• Lead Sponsor: Myriad Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Eligible subjects have dementia with diagnosis of probable Alzheimer s disease by the Diagnostic and Statistical Manual of Mental Disorders, version IV text revised DSM-IV TR and the NINCDS-ADRDA criteria, and Mini Mental Status Exam MMSE score between 20 and 26 inclusive; age 8805; 55. Acetylcholinesterase inhibitors are permitted if therapy was started at least 6 months prior to enrollment. Memantine is permitted if therapy with stable doses was started at least 3 months prior to enrollment. Stable doses of antipsychotics, anxiolytics, antidepressants and low dose aspirin are permitted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
Eligible subjects have dementia with diagnosis of probable Alzheimer s disease by the Diagnostic and Statistical Manual of Mental Disorders, version IV text revised DSM-IV TR and the NINCDS-ADRDA criteria, and Mini Mental Status Exam MMSE score between 20 and 26 inclusive; age 8805; 55. Acetylcholinesterase inhibitors are permitted if therapy was started at least 6 months prior to enrollment. Memantine is permitted if therapy with stable doses was started at least 3 months prior to enrollment. Stable doses of antipsychotics, anxiolytics, antidepressants and low dose aspirin are permitted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusions include diagnosis of other organic neurologic conditions, uncontrolled medical conditions cardiac, renal, hepatic or metabolic , active malignancy, chronic nonsteroidal antiinflammatory drugs use, and treatment with CYP2C9 inhibitors.
;
Exclusions include diagnosis of other organic neurologic conditions, uncontrolled medical conditions cardiac, renal, hepatic or metabolic , active malignancy, chronic nonsteroidal antiinflammatory drugs use, and treatment with CYP2C9 inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified