Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: SB-742457
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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: 380
Study Start Date: September 2005
Intervention Details:
    Drug: SB-742457
    Other Name: SB-742457
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224497

  Show 48 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00224497     History of Changes
Other Study ID Numbers: AZ3100603
Study First Received: September 21, 2005
Last Updated: December 23, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by GlaxoSmithKline:
Alzheimer's disease
cognition global functioning
symptomatic
B-742457

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014