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SB-742457 And Donepezil In Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB-742457
donepezil
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, SB-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 Alzheimers 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 or donepezil. Subjects with conditions which might be exacerbated by exposure to donepezil. 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
  • 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 behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status

Full Information

First Posted
June 30, 2006
Last Updated
May 28, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00348192
Brief Title
SB-742457 And Donepezil In Alzheimer's Disease
Official Title
A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (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, SB-742457

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-742457
Intervention Type
Drug
Intervention Name(s)
donepezil
Other 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 behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 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 Alzheimers 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 or donepezil. Subjects with conditions which might be exacerbated by exposure to donepezil. 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
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
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
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
ZIP/Postal Code
7560356
Country
Chile
Facility Name
GSK Investigational Site
City
Valparaiso
State/Province
Valparaíso
ZIP/Postal Code
2352499
Country
Chile
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Ostfildern
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
GSK Investigational Site
City
Huettenberg
State/Province
Hessen
ZIP/Postal Code
35625
Country
Germany
Facility Name
GSK Investigational Site
City
Achim
State/Province
Niedersachsen
ZIP/Postal Code
28832
Country
Germany
Facility Name
GSK Investigational Site
City
Baesweiler
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52499
Country
Germany
Facility Name
GSK Investigational Site
City
Hattingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45525
Country
Germany
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115552
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
197022
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
826 06
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bradford
ZIP/Postal Code
BD7 1HR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Swindon
ZIP/Postal Code
SN1 4HZ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
West of Scotland Science Park, Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20872778
Citation
Maher-Edwards G, Dixon R, Hunter J, Gold M, Hopton G, Jacobs G, Hunter J, Williams P. SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study. Int J Geriatr Psychiatry. 2011 May;26(5):536-44. doi: 10.1002/gps.2562. Epub 2010 Sep 24.
Results Reference
derived

Learn more about this trial

SB-742457 And Donepezil In Alzheimer's Disease

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