Alzheimer's DiseasePhase 2NCT00348192
SB-742457 And Donepezil In Alzheimer's Disease
A Phase 2 study testing SB-742457 and donepezil in people with Alzheimer's Disease, run by GlaxoSmithKline at 26 sites in 8 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 and donepezil
- How many people
- 200 participants
- Where
- 26 sitesin 8 countries
- Study dates
- May 2006to 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 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.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Germany5 sites
GSK Investigational Site
Achim, Lower Saxony, 28832
GSK Investigational Site
Baesweiler, North Rhine-Westphalia, 52499
GSK Investigational Site
Hattingen, North Rhine-Westphalia, 45525
GSK Investigational Site
Hüttenberg, Hesse, 35625
GSK Investigational Site
Ostfildern, Baden-Wurttemberg, 73760
Russia4 sites
GSK Investigational Site
Moscow, 115552
GSK Investigational Site
Moscow, 117049
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Saint Petersburg, 198103
Austria3 sites
GSK Investigational Site
Hall in Tirol, A-6060
GSK Investigational Site
Vienna, A-1130
GSK Investigational Site
Vienna, A-1220
Bulgaria3 sites
GSK Investigational Site
Sofia, 1113
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Varna, 9010
Chile3 sites
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710
GSK Investigational Site
Santiago, Región Metro de Santiago, 7560356
GSK Investigational Site
Valparaíso, Valparaiso, 2352499
Slovakia3 sites
GSK Investigational Site
Bratislava, 811 01
GSK Investigational Site
Bratislava, 826 06
GSK Investigational Site
Bratislava, 831 03
United Kingdom3 sites
GSK Investigational Site
Bradford, BD7 1HR
GSK Investigational Site
Swindon, SN1 4HZ
GSK Investigational Site
West of Scotland Science Park, Glasgow, G20 0XA
Estonia2 sites
GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tartu, 51014
About this study
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
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, donepezil
- Keywords
- Alzheimer's Disease, cognition global functioning, symptomatic, SB-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
donepezilDrug
Also called SB-742457
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 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
- NCT00348192
- Sponsor's protocol ID
- AZ3106242
- Status last verified
- May 2009
- First submitted
- 30 Jun 2006
- Last updated
- 2 Jun 2009
- Results posted
- No
Publications
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.
PubMed 20872778
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00348192
- Acronym / sponsor ID
- AZ3106242
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, cognition global functioning, symptomatic, SB-742457
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 4 Jul 2006 (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 (6 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 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.
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 | – |
| donepezilAlso: SB-742457 | Drug | – |
Primary outcome
Change in cognition and function after 24 weeks.
1 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
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 2 Jun 2009.
- Derived from this study: PubMed 20872778Maher-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.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-742457 and donepezil in people with Alzheimer's Disease, run by GlaxoSmithKline at 26 sites in 8 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 6 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 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Russia, Austria, Bulgaria, Chile and 3 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?
On the ClinicalTrials.gov record for NCT00348192, which also lists 1 linked publication.
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 2 Jun 2009.