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A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB-742457
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, cognition global functioning, symptomatic, B-742457

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
September 21, 2005
Last Updated
December 23, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00224497
Brief Title
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, cognition global functioning, symptomatic, B-742457

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
380 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-742457
Primary Outcome Measure Information:
Title
Change in cognition and function after 24 weeks.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hall in Tirol
ZIP/Postal Code
A-6060
Country
Austria
Facility Name
GSK Investigational Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
GSK Investigational Site
City
Retz
ZIP/Postal Code
A-2070
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1040
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Providencia / Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
Country
Chile
Facility Name
GSK Investigational Site
City
Valparaiso
State/Province
Valparaíso
ZIP/Postal Code
2352499
Country
Chile
Facility Name
GSK Investigational Site
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
GSK Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 18
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Rychnov Nad Kneznou
ZIP/Postal Code
516 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 21
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
151 23
Country
Greece
Facility Name
GSK Investigational Site
City
Melissia
ZIP/Postal Code
151 27
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8002
Country
New Zealand
Facility Name
GSK Investigational Site
City
Mosina
ZIP/Postal Code
62-050
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-082
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St.-Petersburg
ZIP/Postal Code
198103
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
811 08
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
GSK Investigational Site
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
GSK Investigational Site
City
Oakdale
ZIP/Postal Code
7530
Country
South Africa
Facility Name
GSK Investigational Site
City
Rosebank
ZIP/Postal Code
2196
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Sant Cugat Del Vallés/
ZIP/Postal Code
08190
Country
Spain
Facility Name
GSK Investigational Site
City
Tarrasa, Barcelona
ZIP/Postal Code
08221
Country
Spain

12. IPD Sharing Statement

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A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

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