Alzheimer's DiseasePhase 2NCT00224497
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
A Phase 2 study testing SB-742457 in people with Alzheimer's Disease, run by GlaxoSmithKline at 48 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SB-742457
- How many people
- 380 participants
- Where
- 48 sitesin 13 countries
- Study dates
- Sep 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 13 countries.
48 sites in 13 countries
Slovakia6 sites
GSK Investigational Site
Bratislava, 811 01
GSK Investigational Site
Bratislava, 811 07
GSK Investigational Site
Bratislava, 811 08
GSK Investigational Site
Bratislava, 826 06
GSK Investigational Site
Košice, 041 66
GSK Investigational Site
Rimavská Sobota, 979 12
Spain6 sites
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08014
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Sant Cugat Del Vallés/, 08190
GSK Investigational Site
Tarrasa, Barcelona, 08221
Austria5 sites
GSK Investigational Site
Hall in Tirol, A-6060
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Retz, A-2070
GSK Investigational Site
Vienna, A-1040
GSK Investigational Site
Vienna, A-1130
Bulgaria5 sites
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Sofia, 1113
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Sofia, 1527
GSK Investigational Site
Varna, 9010
Czechia4 sites
GSK Investigational Site
Olomouc, 775 20
GSK Investigational Site
Ostrava, 702 00
GSK Investigational Site
Prague, 150 18
GSK Investigational Site
Rychnov nad Kněžnou, 516 01
Greece4 sites
GSK Investigational Site
Athens, 115 21
GSK Investigational Site
Athens, 151 23
GSK Investigational Site
Melíssia, 151 27
GSK Investigational Site
Thessaloniki, 57010
Chile3 sites
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Valparaíso, Valparaiso, 2352499
Poland3 sites
GSK Investigational Site
Mosina, 62-050
GSK Investigational Site
Olsztyn, 10-082
GSK Investigational Site
Warsaw, 02-097
Russia3 sites
GSK Investigational Site
Moscow, 115522
GSK Investigational Site
Moscow, 117049
GSK Investigational Site
Saint Petersburg, 198103
South Africa3 sites
GSK Investigational Site
Oakdale, 7530
GSK Investigational Site
Rosebank, 2196
GSK Investigational Site
Somerset West, 7130
Croatia2 sites
GSK Investigational Site
Split, 21000
GSK Investigational Site
Zagreb, 10000
New Zealand2 sites
GSK Investigational Site
Auckland, 1309
GSK Investigational Site
Christchurch, 8002
South Korea2 sites
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 150-719
About this study
Official 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
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
- Being tested
- SB-742457
- Keywords
- Alzheimer's disease, cognition global functioning, symptomatic, B-742457
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-742457Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 380 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224497
- Sponsor's protocol ID
- AZ3100603
- Status last verified
- Dec 2009
- First submitted
- 21 Sep 2005
- Last updated
- 24 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00224497
- Acronym / sponsor ID
- AZ3100603
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, cognition global functioning, symptomatic, B-742457
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-742457 | Drug | – |
Primary outcome
Change in cognition and function after 24 weeks.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
48 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-742457 in people with Alzheimer's Disease, run by GlaxoSmithKline at 48 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Slovakia, Spain, Austria, Bulgaria, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognition and function after 24 weeks.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.