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CompletedNCT00224497Updated Dec 24, 2009

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

A Phase 2 interventional study of SB-742457 in Alzheimer's Disease, sponsored by GlaxoSmithKline. Completed at 48 sites in 13 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-12-24.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
380
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
  • cognition global functioning
  • symptomatic
  • B-742457
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 380 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
380 participants

Interventions

  • DrugSB-742457
06

What researchers measure

Primary outcomes

  1. Change in cognition and function after 24 weeks.

Secondary outcomes

  1. 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.

07

Study locations

48 sites
  • GSK Investigational Site
    Hall in Tirol, A-6060, Austria
  • GSK Investigational Site
    Innsbruck, A-6020, Austria
  • GSK Investigational Site
    Retz, A-2070, Austria
  • GSK Investigational Site
    Vienna, A-1040, Austria
  • GSK Investigational Site
    Vienna, A-1130, Austria
  • GSK Investigational Site
    Plovdiv, 4000, Bulgaria
  • GSK Investigational Site
    Sofia, 1113, Bulgaria
  • GSK Investigational Site
    Sofia, 1431, Bulgaria
  • GSK Investigational Site
    Sofia, 1527, Bulgaria
  • GSK Investigational Site
    Varna, 9010, Bulgaria
  • GSK Investigational Site
    Providencia / Santiago, Región Metro De Santiago 7500710, Chile
  • GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile
  • GSK Investigational Site
    Valparaiso, Valparaíso 2352499, Chile
  • GSK Investigational Site
    Split, 21000, Croatia
  • GSK Investigational Site
    Zagreb, 10000, Croatia
  • GSK Investigational Site
    Olomouc, 775 20, Czech Republic
  • GSK Investigational Site
    Ostrava, 702 00, Czech Republic
  • GSK Investigational Site
    Praha 5, 150 18, Czech Republic
  • GSK Investigational Site
    Rychnov Nad Kneznou, 516 01, Czech Republic
  • GSK Investigational Site
    Athens, 115 21, Greece
  • GSK Investigational Site
    Athens, 151 23, Greece
  • GSK Investigational Site
    Melissia, 151 27, Greece
  • GSK Investigational Site
    Thessaloniki, 57010, Greece
  • GSK Investigational Site
    Seoul, 135-710, Korea, Republic of
  • GSK Investigational Site
    Seoul, 150-719, Korea, Republic of
  • GSK Investigational Site
    Auckland, 1309, New Zealand
  • GSK Investigational Site
    Christchurch, 8002, New Zealand
  • GSK Investigational Site
    Mosina, 62-050, Poland
  • GSK Investigational Site
    Olsztyn, 10-082, Poland
  • GSK Investigational Site
    Warszawa, 02-097, Poland
  • GSK Investigational Site
    Moscow, 115522, Russian Federation
  • GSK Investigational Site
    Moscow, 117049, Russian Federation
  • GSK Investigational Site
    St.-Petersburg, 198103, Russian Federation
  • GSK Investigational Site
    Bratislava, 811 01, Slovakia
  • GSK Investigational Site
    Bratislava, 811 07, Slovakia
  • GSK Investigational Site
    Bratislava, 811 08, Slovakia
  • GSK Investigational Site
    Bratislava, 826 06, Slovakia
  • GSK Investigational Site
    Kosice, 041 66, Slovakia
  • GSK Investigational Site
    Rimavska Sobota, 979 12, Slovakia
  • GSK Investigational Site
    Oakdale, 7530, South Africa
  • GSK Investigational Site
    Rosebank, 2196, South Africa
  • GSK Investigational Site
    Somerset West, 7130, South Africa
  • GSK Investigational Site
    Barcelona, 08003, Spain
  • GSK Investigational Site
    Barcelona, 08014, Spain
  • GSK Investigational Site
    Barcelona, 08025, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Sant Cugat Del Vallés/, 08190, Spain
  • GSK Investigational Site
    Tarrasa, Barcelona, 08221, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00224497
Lead sponsor
GlaxoSmithKline
First posted
Sep 23, 2005
Start date
Sep 2005
Last update
Dec 24, 2009

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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