Alzheimer's DiseasePhase 1NCT01424436
Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient
A Phase 1 study testing GSK933776 in people with Alzheimer's Disease, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- GSK933776
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 19 May 2010to 8 Dec 2011
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
- Increase in total tau or p-tau in CSF
- Decrease in amyloid beta in CSF
- Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
- Body weight less than 120 kg
- Willingness to comply with contraceptive methods if self or partner is of child-bearing potential
Who cannot join
- Any other cause of dementia
- Other significant neurologic or psychiatric illness
- Hachinski Ischemia Score >4
- More than 3 microbleeds on MRI
- Type 2 diabetes not controlled by diet
- Risk of cerebrovascular disease, cerebral haemorrhage or stroke
Show all 14Show fewer
- History of systemic autoimmune disease
- Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)
- Use of chronic corticosteroids
- Uncontrolled hypertension in spite of antihypertensive medications
- Renal or hepatic insufficiency or clinically significant anaemia
- In nursing home care
- Contraindications to lumbar puncture or MRI
- Prior participation in therapeutic studies only after adequate wash-out period
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68159
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89081
Sweden2 sites
GSK Investigational Site
Malmö, SE-212 24
GSK Investigational Site
Stockholm, se-141 86
About this study
Official title: Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
Read the detailed description
This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.
- Conditions
- Alzheimer's Disease
- Being tested
- GSK933776
- Keywords
- CSF sampling, Alzheimer's disease, Amyloid beta levels
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK933776Biological
1mg/kg dose group
GSK933776Biological
3mg/kg dose group
GSK933776Biological
6mg/kg dose group
| Study group | Role | What they receive |
|---|---|---|
| GSK933776 1mg/kg | Experimental | single dose Receives: Biological: GSK933776 |
| GSK933776 0.1 or 3mg/kg | Experimental | single dose Receives: Biological: GSK933776 |
| GSK933776 3 or 6mg/kg | Experimental | single dose Receives: Biological: GSK933776 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours
Measured: 22 hours
Secondary outcomes (4)
The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Measured: Two months
The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Measured: 22 hours
Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.
Measured: three months
To assess the safety and tolerability after single dose of GSK933776 administration.
The safety and tolerability measures are performed at screening, dosing day and follow up. The assessments included: • Adverse event reporting and safety laboratory data. • CNS Safety: MRI and MMSE. • CVS safety: ECG and vital signs. •Anti-GSK933776 antibodies.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study start19 May 2010
- Primary completion8 Dec 2011
- Study completion8 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT01424436
- Sponsor's protocol ID
- 113043
- Status last verified
- Jun 2017
- First submitted
- 4 Aug 2011
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- 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
Andreasen N, Simeoni M, Ostlund H, Lisjo PI, Fladby T, Loercher AE, Byrne GJ, Murray F, Scott-Stevens PT, Wallin A, Zhang YY, Bronge LH, Zetterberg H, Nordberg AK, Yeo AJ, Khan SA, Hilpert J, Mistry PC. First administration of the Fc-attenuated anti-beta amyloid antibody GSK933776 to patients with mild Alzheimer's disease: a randomized, placebo-controlled study. PLoS One. 2015 Mar 19;10(3):e0098153. doi: 10.1371/journal.pone.0098153. eCollection 2015.
PubMed 25789616Leyhe T, Andreasen N, Simeoni M, Reich A, von Arnim CA, Tong X, Yeo A, Khan S, Loercher A, Chalker M, Hottenstein C, Zetterberg H, Hilpert J, Mistry P. Modulation of beta-amyloid by a single dose of GSK933776 in patients with mild Alzheimer's disease: a phase I study. Alzheimers Res Ther. 2014 Apr 9;6(2):19. doi: 10.1186/alzrt249. eCollection 2014.
PubMed 24716469
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01424436
- Acronym / sponsor ID
- 113043
- Conditions
- Alzheimer's Disease
- Keywords
- CSF sampling, Alzheimer's disease, Amyloid beta levels
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 May 2010 (actual)
- Primary completion
- 8 Dec 2011 (actual)
- Study completion
- 8 Dec 2011 (actual)
- First posted
- 29 Aug 2011 (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.
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
Detailed description
This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK933776 1mg/kg | Experimental | Biological: GSK933776single dose |
| GSK933776 0.1 or 3mg/kg | Experimental | Biological: GSK933776single dose |
| GSK933776 3 or 6mg/kg | Experimental | Biological: GSK933776single dose |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
- Increase in total tau or p-tau in CSF
- Decrease in amyloid beta in CSF
- Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
- Body weight less than 120 kg
Key exclusion criteria (14 listed)
- Any other cause of dementia
- Other significant neurologic or psychiatric illness
- Hachinski Ischemia Score >4
- More than 3 microbleeds on MRI
- Type 2 diabetes not controlled by diet
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 |
|---|---|---|
| GSK9337761mg/kg dose group | Biological | GSK933776 1mg/kg |
| GSK9337763mg/kg dose group | Biological | GSK933776 0.1 or 3mg/kg |
| GSK9337766mg/kg dose group | Biological | GSK933776 3 or 6mg/kg |
Primary outcome
The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Time frame: 22 hours
To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours
4 secondary outcomes
The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Time frame: Two months
The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Time frame: 22 hours
Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.
Time frame: three months
To assess the safety and tolerability after single dose of GSK933776 administration.
Time frame: three months
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 14 Jun 2017.
- Derived from this study: PubMed 25789616Andreasen N, Simeoni M, Ostlund H, Lisjo PI, Fladby T, Loercher AE, Byrne GJ, Murray F, Scott-Stevens PT, Wallin A, Zhang YY, Bronge LH, Zetterberg H, Nordberg AK, Yeo AJ, Khan SA, Hilpert J, Mistry PC. First administration of the Fc-attenuated anti-beta amyloid antibody GSK933776 to patients with mild Alzheimer's disease: a randomized, placebo-controlled study. PLoS One. 2015 Mar 19;10(3):e0098153. doi: 10.1371/journal.pone.0098153. eCollection 2015.
- Derived from this study: PubMed 24716469Leyhe T, Andreasen N, Simeoni M, Reich A, von Arnim CA, Tong X, Yeo A, Khan S, Loercher A, Chalker M, Hottenstein C, Zetterberg H, Hilpert J, Mistry P. Modulation of beta-amyloid by a single dose of GSK933776 in patients with mild Alzheimer's disease: a phase I study. Alzheimers Res Ther. 2014 Apr 9;6(2):19. doi: 10.1186/alzrt249. eCollection 2014.
- 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 113043 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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK933776 in people with Alzheimer's Disease, run by GlaxoSmithKline at 7 sites in 2 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 6 inclusion and 14 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Sweden. 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 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?
The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment (time frame: 22 hours). 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 NCT01424436, which also lists 2 linked publications.
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 14 Jun 2017.