Trial record 5 of 5 for:
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
This study has been completed.
Information provided by:
First received: September 21, 2005
Last updated: December 23, 2009
Last verified: December 2009
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Change in cognition and function after 24 weeks.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
Other Name: SB-742457
|Ages Eligible for Study:
||50 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224497
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2005
||December 23, 2009
||Austria: Federal Ministry for Health and Women
Keywords provided by GlaxoSmithKline:
cognition global functioning
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders