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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00224497




Registration number
NCT00224497
Ethics application status
Date submitted
21/09/2005
Date registered
23/09/2005
Date last updated
24/12/2009

Titles & IDs
Public title
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
Scientific title
A Phase IIa/b Double-blind, Randomised, Placebo-controlled, Linear Trend Design Dose-ranging Study to Investigate the Effects of 24 Weeks of Monotherapy With SB-742457 on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
AZ3100603
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB-742457

Treatment: Drugs: SB-742457
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in cognition and function after 24 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion 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.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Hall in Tirol
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Retz
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Plovdiv
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Varna
Country [8] 0 0
Chile
State/province [8] 0 0
Región Metro De Santiago
Country [9] 0 0
Chile
State/province [9] 0 0
Valparaíso
Country [10] 0 0
Croatia
State/province [10] 0 0
Split
Country [11] 0 0
Croatia
State/province [11] 0 0
Zagreb
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Olomouc
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Ostrava
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha 5
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Rychnov Nad Kneznou
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Greece
State/province [17] 0 0
Melissia
Country [18] 0 0
Greece
State/province [18] 0 0
Thessaloniki
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Christchurch
Country [22] 0 0
Poland
State/province [22] 0 0
Mosina
Country [23] 0 0
Poland
State/province [23] 0 0
Olsztyn
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Russian Federation
State/province [26] 0 0
St.-Petersburg
Country [27] 0 0
Slovakia
State/province [27] 0 0
Bratislava
Country [28] 0 0
Slovakia
State/province [28] 0 0
Kosice
Country [29] 0 0
Slovakia
State/province [29] 0 0
Rimavska Sobota
Country [30] 0 0
South Africa
State/province [30] 0 0
Oakdale
Country [31] 0 0
South Africa
State/province [31] 0 0
Rosebank
Country [32] 0 0
South Africa
State/province [32] 0 0
Somerset West
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Sant Cugat Del Vallés/
Country [36] 0 0
Spain
State/province [36] 0 0
Tarrasa, Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00224497
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00224497