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

NCT00224497 | Completed Phase 2

• 1 other identifier: AZ3100603
• Study Type: interventional
• Target: 380
• Locations: 13 countries
• Sites: 48

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; cognition global functioning; symptomatic; B-742457

Outcome Measures

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.

Interventions

SB-742457 DRUG

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (48)

GSK Investigational Site

Hall in Tirol, A-6060, Austria

Location

GSK Investigational Site

Innsbruck, A-6020, Austria

Location

GSK Investigational Site

Retz, A-2070, Austria

Location

GSK Investigational Site

Vienna, A-1040, Austria

Location

GSK Investigational Site

Vienna, A-1130, Austria

Location

GSK Investigational Site

Plovdiv, 4000, Bulgaria

Location

GSK Investigational Site

Sofia, 1113, Bulgaria

Location

GSK Investigational Site

Sofia, 1431, Bulgaria

Location

GSK Investigational Site

Sofia, 1527, 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, Chile

Location

GSK Investigational Site

Split, 21000, Croatia

Location

GSK Investigational Site

Zagreb, 10000, Croatia

Location

GSK Investigational Site

Olomouc, 775 20, Czechia

Location

GSK Investigational Site

Ostrava, 702 00, Czechia

Location

GSK Investigational Site

Prague, 150 18, Czechia

Location

GSK Investigational Site

Rychnov nad Kněžnou, 516 01, Czechia

Location

GSK Investigational Site

Athens, 115 21, Greece

Location

GSK Investigational Site

Athens, 151 23, Greece

Location

GSK Investigational Site

Melíssia, 151 27, Greece

Location

GSK Investigational Site

Thessaloniki, 57010, Greece

Location

GSK Investigational Site

Auckland, 1309, New Zealand

Location

GSK Investigational Site

Christchurch, 8002, New Zealand

Location

GSK Investigational Site

Mosina, 62-050, Poland

Location

GSK Investigational Site

Olsztyn, 10-082, Poland

Location

GSK Investigational Site

Warsaw, 02-097, Poland

Location

GSK Investigational Site

Moscow, 115522, Russia

Location

GSK Investigational Site

Moscow, 117049, Russia

Location

GSK Investigational Site

Saint Petersburg, 198103, Russia

Location

GSK Investigational Site

Bratislava, 811 01, Slovakia

Location

GSK Investigational Site

Bratislava, 811 07, Slovakia

Location

GSK Investigational Site

Bratislava, 811 08, Slovakia

Location

GSK Investigational Site

Bratislava, 826 06, Slovakia

Location

GSK Investigational Site

Košice, 041 66, Slovakia

Location

GSK Investigational Site

Rimavská Sobota, 979 12, Slovakia

Location

GSK Investigational Site

Oakdale, 7530, South Africa

Location

GSK Investigational Site

Rosebank, 2196, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 150-719, South Korea

Location

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Barcelona, 08014, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Sant Cugat Del Vallés/, 08190, Spain

Location

GSK Investigational Site

Tarrasa, Barcelona, 08221, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

3-benzenesulfonyl-8-piperazin-1-ylquinoline

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

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: September 21, 2005
• First Posted: September 23, 2005
• Study Start: September 1, 2005
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

BU (5); KR (2); CL (3); PL (3); GR (4); CZ (4); NZ (2); RU (3); ES (6); SL (6); ZA (3); CR (2); AU (5)