Alzheimer's DiseasePhase 1NCT00675090
Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease
A Phase 1 study testing GSK239512 in people with Alzheimer's Disease, run by GlaxoSmithKline at 8 sites in 4 countries.
Trial summary
This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- GSK239512
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 21 Feb 2008to 16 Jun 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with a clinical diagnosis of probable Alzheimer's disease
- The subject has an MMSE score at screening of 12 to 26 for Part A and 16-26 for Part B.
- Age ≥ 50 and above.
- If female, the subject must be post-menopausal (i.e. 12 months without menstrual period) or surgically sterile.
- Male subjects must be willing to abstain from sexual intercourse with pregnant or lactating women; or be willing to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant, from the time of the first dose of GSK239512 until 84 days following completion of the study.
- The subject has the ability to comply with the study procedures.
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- The subject has a permanent caregiver and is willing to attend all study visits for Parts A and B.
- The subject has provided full written informed consent prior to the performance of any protocol specific procedure, or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
- The caregiver has provided his / her written consent prior to the performance of any protocol specific procedure.
Who cannot join
- In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia
- History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (a score of ≥8 on the Cornell Scale for Depression in Dementia), or subjects with other psychiatric features in their AD which would in the opinion of the investigator, would increase risk to safety.
- History of significant sleep disturbance, for example, when it is associated with nocturnal wandering, nocturnal confusion / disorientation / agitation, which in the opinion of the investigator, may increase safety risk.
- History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
- History or presence of significant cardiovascular, gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- History of alcohol or other substance abuse, according to the Diagnostic and Statistical Manual of Mental Disorders - Substance related disorders (DSM-IV) criteria.
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- Clinically significant abnormalities in laboratory tests, including subjects with active liver disease or uncontrolled thyroid disease.
- Uncontrolled hypertension with systolic BP ≥160 and/or diastolic ≥95 mmHg. Subjects with controlled hypertension with systolic BP < 160 mmHg and diastolic <95 mmHg for at least 4 weeks are acceptable.
- Systolic BP <100 mmHg and/or diastolic <60 mmHg.
- Subjects with ECG criteria outside ranges specified in the protocol
- History of hypersensitivity to GSK239512 or its excipients.
- Treatment with cholinesterase inhibitors, (including Tacrine), memantine or selegiline within the previous month. No patients with AD who are already on these medications at the time of screening will be recruited, as it would be unethical to withdraw these medications for study participation. Only AD subjects who are not yet on these medications, or who have withdrawn from these medications for other reasons previously, may be enrolled into this study.
- Subjects who are currently taking or who have taken in the last month anti-psychotic drugs (typical or atypical dopaminergic antagonists or modulators) or mood stabilization drugs (including SSRI, DNRI, SNRI, MAO inhibitors, tricyclic antidepressants, lithium, valproate, carbamazepine).
- Subjects who are currently taking Pgp inhibitors or any CYP3A4 inhibitors.
- Subjects on chronic sedative medications (≥ 4 days per week for the past 4 weeks).
- Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
- Has received any other investigational treatment in the previous 3 months.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom3 sites
GSK Investigational Site
Cambridgeshire, Cambridgeshire, CB2 2QQ
GSK Investigational Site
London, SE1 1YR
GSK Investigational Site
Southall, UB1 3HW
Australia2 sites
GSK Investigational Site
Heidelberg Heights, Victoria, 3084
GSK Investigational Site
Randwick, New South Wales, 2031
South Korea2 sites
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 138-736
About this study
Official title: A Single Blind, Placebo-controlled, Randomised Study in Mild to Moderate Alzheimer's Disease Patients to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK239512, a Selective Histamine H3 Receptor Antagonist
This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients.
- Conditions
- Alzheimer's Disease
- Being tested
- GSK239512, Placebo
- Keywords
- Alzheimers Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK239512Drug
GSK239512 oral tablets once a day
PlaceboDrug
Placebo tablets to match once a day
| Study group | Role | What they receive |
|---|---|---|
| GSK239512 | Experimental | GSK239512 oral tablets Receives: Drug: GSK239512 |
| Placebo | Placebo comparator | Placebo to match tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements and validated clinical assessment scales.
Measured: Days 8, 15, 22 and 29
Secondary outcomes (1)
Pharmacodynamics measured by computerized cognitive tests and validated clinical rating scales. Also investigating the Pharmacokineticsat trough concentrations (Cmin) after GSK239512 repeat dosing on days 8, 15, 22 and 29 and 15.
Measured: days 8, 15, 22 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study start21 Feb 2008
- Primary completion16 Jun 2009
- Study completion16 Jun 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675090
- Sponsor's protocol ID
- H3B109689
- Status last verified
- Jul 2017
- First submitted
- 24 Apr 2008
- Last updated
- 7 Jul 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Nathan PJ, Boardley R, Scott N, Berges A, Maruff P, Sivananthan T, Upton N, Lowy MT, Nestor PJ, Lai R. The safety, tolerability, pharmacokinetics and cognitive effects of GSK239512, a selective histamine H(3) receptor antagonist in patients with mild to moderate Alzheimer's disease: a preliminary investigation. Curr Alzheimer Res. 2013 Mar;10(3):240-51. doi: 10.2174/1567205011310030003.
PubMed 23521503
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Placebo-controlled, Randomised Study in Mild to Moderate Alzheimer's Disease Patients to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK239512, a Selective Histamine H3 Receptor Antagonist
- ClinicalTrials.gov ID
- NCT00675090
- Acronym / sponsor ID
- H3B109689
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimers Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2008 (actual)
- Primary completion
- 16 Jun 2009 (actual)
- Study completion
- 16 Jun 2009 (actual)
- First posted
- 8 May 2008 (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.
This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK239512 | Experimental | Drug: GSK239512GSK239512 oral tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match tablets |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects with a clinical diagnosis of probable Alzheimer's disease
- The subject has an MMSE score at screening of 12 to 26 for Part A and 16-26 for Part B.
- Age ≥ 50 and above.
- If female, the subject must be post-menopausal (i.e. 12 months without menstrual period) or surgically sterile.
- Male subjects must be willing to abstain from sexual intercourse with pregnant or lactating women; or be willing to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant, from the time of the first dose of GSK239512 until 84 days following completion of the study.
Key exclusion criteria (17 listed)
- In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia
- History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (a score of ≥8 on the Cornell Scale for Depression in Dementia), or subjects with other psychiatric features in their AD which would in the opinion of the investigator, would increase risk to safety.
- History of significant sleep disturbance, for example, when it is associated with nocturnal wandering, nocturnal confusion / disorientation / agitation, which in the opinion of the investigator, may increase safety risk.
- History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
- History or presence of significant cardiovascular, gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
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 |
|---|---|---|
| GSK239512GSK239512 oral tablets once a day | Drug | GSK239512 |
| PlaceboPlacebo tablets to match once a day | Drug | Placebo |
Primary outcome
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements and validated clinical assessment scales.
Time frame: Days 8, 15, 22 and 29
1 secondary outcome
Pharmacodynamics measured by computerized cognitive tests and validated clinical rating scales. Also investigating the Pharmacokineticsat trough concentrations (Cmin) after GSK239512 repeat dosing on days 8, 15, 22 and 29 and 15.
Time frame: days 8, 15, 22 and 29
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 7 Jul 2017.
- Background: PubMed 23521503Nathan PJ, Boardley R, Scott N, Berges A, Maruff P, Sivananthan T, Upton N, Lowy MT, Nestor PJ, Lai R. The safety, tolerability, pharmacokinetics and cognitive effects of GSK239512, a selective histamine H(3) receptor antagonist in patients with mild to moderate Alzheimer's disease: a preliminary investigation. Curr Alzheimer Res. 2013 Mar;10(3):240-51. doi: 10.2174/1567205011310030003.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study H3B109689 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 study director
GlaxoSmithKline
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK239512 in people with Alzheimer's Disease, run by GlaxoSmithKline at 8 sites in 4 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 9 inclusion and 17 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 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Australia, South Korea, Czechia. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements and validated clinical assessment scales. (time frame: Days 8, 15, 22 and 29). 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 NCT00675090, 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 7 Jul 2017.