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SB-742457 And Donepezil In Alzheimer's Disease

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: SB-742457 (Drug); donepezil (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in cognition and function after 24 weeks.

Secondary outcome:

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

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Both.

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 or donepezil.

- Subjects with conditions which might be exacerbated by exposure to donepezil.

- Subjects with known hypersensitivity to sunlight or seizures.

Locations and Contacts

GSK Clinical Trials Call Center, Vienna A1220, Austria

GSK Clinical Trials Call Center, Vienna A1130, Austria

GSK Clinical Trials Call Center, Tirol A6060, Austria

GSK Clinical Trials Call Center, Sofia 1113, Bulgaria

GSK Clinical Trials Call Center, Sofia 1431/1000, Bulgaria

GSK Clinical Trials Call Center, Sofia 1113, Bulgaria

GSK Clinical Trials Call Center, Varna 9010, Bulgaria

GSK Clinical Trials Call Center, Santiago 756-0356, Chile

GSK Clinical Trials Call Center, Valparaiso 238-1594, Chile

GSK Clinical Trials Call Center, Santiago 750-0710, Chile

GSK Clinical Trials Call Center, Tallinn 10617, Estonia

GSK Clinical Trials Call Center, Tartu 51014, Estonia

GSK Clinical Trials Call Center, Voru 65609, Estonia

GSK Clinical Trials Call Center, Achim 28832, Germany

GSK Clinical Trials Call Center, Ostfildern 73670, Germany

GSK Clinical Trials Call Center, Hattingen 45525, Germany

GSK Clinical Trials Call Center, Huettenberg 35625, Germany

GSK Clinical Trials Call Center, Baesweiler 52499, Germany

GSK Clinical Trials Call Center, Szeged 6720, Hungary

GSK Clinical Trials Call Center, Debrecen 4010, Hungary

GSK Clinical Trials Call Center, St Petersburg 198103, Russian Federation

GSK Clinical Trials Call Center, Moscow 117049, Russian Federation

GSK Clinical Trials Call Center, St Petersburg 197022, Russian Federation

GSK Clinical Trials Call Center, Moscow 115522, Russian Federation

GSK Clinical Trials Call Center, Bratislava 83103, Slovakia

GSK Clinical Trials Call Center, Bratislava 81101, Slovakia

GSK Clinical Trials Call Center, Bratislava 82606, Slovakia

GSK Clinical Trials Call Center, Glasgow GH1 4HX, United Kingdom

GSK Clinical Trials Call Center, Swindon SN1 4HZ, United Kingdom

GSK Clinical Trials Call Center, Blackpool FY2 0JW, United Kingdom

GSK Clinical Trials Call Center, Stoke-on-Trent ST4 6QG, United Kingdom

Additional Information

Starting date: May 2006
Last updated: November 2, 2006

Page last updated: March 21, 2008

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