NCT00348192

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
8 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

June 2, 2009

Status Verified

May 1, 2009

First QC Date

June 30, 2006

Last Update Submit

May 28, 2009

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Diseasecognition global functioningsymptomaticSB-742457

Outcome Measures

Primary Outcomes (1)

  • Change in cognition and function after 24 weeks.

Secondary Outcomes (1)

  • 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

Interventions

SB-742457DRUG
donepezilDRUG
Also known as: SB-742457

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

GSK Investigational Site

Hall in Tirol, A-6060, Austria

Location

GSK Investigational Site

Vienna, A-1130, Austria

Location

GSK Investigational Site

Vienna, A-1220, Austria

Location

GSK Investigational Site

Sofia, 1113, Bulgaria

Location

GSK Investigational Site

Sofia, 1431, Bulgaria

Location

GSK Investigational Site

Varna, 9010, Bulgaria

Location

GSK Investigational Site

Valparaíso, Región de Valparaíso, 2352499, Chile

Location

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, 7500710, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7560356, Chile

Location

GSK Investigational Site

Tallinn, 10617, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Ostfildern, Baden-Wurttemberg, 73760, Germany

Location

GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

Location

GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

Location

GSK Investigational Site

Baesweiler, North Rhine-Westphalia, 52499, Germany

Location

GSK Investigational Site

Hattingen, North Rhine-Westphalia, 45525, Germany

Location

GSK Investigational Site

Moscow, 115552, Russia

Location

GSK Investigational Site

Moscow, 117049, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saint Petersburg, 198103, Russia

Location

GSK Investigational Site

Bratislava, 811 01, Slovakia

Location

GSK Investigational Site

Bratislava, 826 06, Slovakia

Location

GSK Investigational Site

Bratislava, 831 03, Slovakia

Location

GSK Investigational Site

Bradford, BD7 1HR, United Kingdom

Location

GSK Investigational Site

Swindon, SN1 4HZ, United Kingdom

Location

GSK Investigational Site

West of Scotland Science Park, Glasgow, G20 0XA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20872778DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinolineDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

May 1, 2006

Last Updated

June 2, 2009

Record last verified: 2009-05

Locations

GB(3)CL(3)ES(2)AU(3)DE(5)SL(3)BU(3)RU(4)