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Trial record 5 of 5 for:    SB742457
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A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00224497
First received: September 21, 2005
Last updated: December 23, 2009
Last verified: December 2009
History of Changes

September 21, 2005
December 23, 2009
September 2005
Not Provided
Change in cognition and function after 24 weeks.
Same as current
Complete list of historical versions of study NCT00224497 on ClinicalTrials.gov Archive Site
Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerability. PK and dose response profiling. Efficacy related to ApoE status.
Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerbility. PK and dose response profiling. Efficacy related to ApoE status.
Not Provided
Not Provided
 
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
A Phase IIa/b Double-blind, Randomised, Placebo-controlled, Linear Trend Design Dose-ranging Study to Investigate the Effects of 24 Weeks of Monotherapy With SB-742457 on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
Drug: SB-742457
Other Name: SB-742457
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
Not Provided
Not Provided

Inclusion criteria:

  • Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.
  • Subjects and their caregivers must provide informed consent prior to study entry.
  • Adequate blood pressure and laboratory values.

Exclusion criteria:

  • Females of child-bearing potential.
  • Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
  • Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes.
  • Subjects taking agents for which there is a theoretical risk of interaction with SB-742457.
  • Subjects with known hypersensitivity to sunlight or seizures.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Chile,   Croatia,   Czech Republic,   Greece,   Korea, Republic of,   New Zealand,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain
 
NCT00224497
AZ3100603
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP