Alzheimer's DiseasePhase 2NCT01148498
A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's
A Phase 2 study testing solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this trial is to compare the average change in the amount of amyloid beta species in blood after an infusion of solanezumab. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- solanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2012
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals in Groups 1, 2, and 3, described below, will be participants in the longitudinal studies of memory and aging at the Washington University Alzheimer's Disease Research Center (WU-ADRC). These participants must have results from apolipoprotein E (ApoE) genotyping from the WU-ADRC. At the beginning of the study they must be between 45 and 90 years of age and if a female of childbearing potential, not be breastfeeding, test negative for pregnancy, and be using a medically accepted form of birth control at the time of the infusion and for 6 months afterward. Subjects must also meet the criteria below for each study group
- Group 1, Mild dementia of Alzheimer's type (DAT):
- Have mild DAT, as determined by Clinical Dementia Rating (CDR) of 0.5 or 1
- Have florbetapir PET imaging findings consistent with underlying AD pathology.
- Group 2, Older Adult Controls with Possible AD Pathology:
- Have no cognitive impairment as indicated by a CDR rating of 0. Have possible AD pathology, as determined by florbetapir PET imaging.
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- Group 3, Older Adult Controls with No Evidence of AD Pathology:
- Have no cognitive impairment as indicated by a CDR rating of 0. Have no evidence of AD pathology as determined by florbetapir PET imaging.
- Individuals recruited into Group 4 will not be participants in the longitudinal studies of memory and aging at WU-ADRC. To be included in Group 4, individuals must meet these criteria:
- Are at least 18 years and <35 years of age at the beginning of the study and if a female of childbearing potential, is not breastfeeding, tests negative for pregnancy and is using highly effective contraception at the time of the solanezumab infusion and for 6 months following infusion
- Have a Folstein Mini-Mental State Examination (MMSE) score of 29 to 30 at the beginning of the study
Who cannot join
- Have previously completed or withdrawn from this study or any other study investigating solanezumab
- Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
- Has allergies to humanized monoclonal antibodies
- Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- Has a history of chronic alcohol or drug abuse/dependence
- Is clinically judged by the investigator to be at serious risk for suicide
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- Has a recent (within 6 months before screening) or current laboratory result (if available) indicating a clinically significant laboratory abnormality
- Has Electrocardiogram (ECG) abnormalities obtained at screening that, in the opinion of the investigator, are clinically significant with regard to the subject's participation in the study. Bazett's corrected QT [QTcB] interval must be evaluated and must not exceed >458 msec in males or >474 msec in females
- At screening, has alanine transaminase (ALT/SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values greater than or equal to 3 times the ULN, or total bilirubin values greater than or equal to 2 times the ULN
- Has had IgG therapy (sometimes called gamma globulin therapy) within the last year or previous participation in any other study investigating active immunization against Aβ
- Requires treatment with other monoclonal antibodies
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, 63108
About this study
Official title: Plasma Amyloid Beta Species After a Single Solanezumab Infusion in Nondemented Individuals and Those With Mild Dementia of the Alzheimer's Type
The purpose of this trial is to compare the average change in the amount of amyloid beta species in blood after an infusion of solanezumab.
- Conditions
- Alzheimer's Disease
- Being tested
- solanezumab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solanezumabDrug
Also called LY2062430, A Beta Antibody
400mg administered once intravenously
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Older adults with mild Dementia Alzheimer's Type (DAT) Receives: Drug: solanezumab |
| Group 2 | Experimental | Older adult controls with possible Alzheimer's Disease Pathology Receives: Drug: solanezumab |
| Group 3 | Experimental | Older adult controls with no evidence of Alzheimer's Disease Receives: Drug: solanezumab |
| Group 4 | Experimental | Younger subjects who are assumed to have no cognitive impairment Receives: Drug: solanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)
Measured: Baseline up to 112 days post drug administration
Secondary outcomes (3)
Mean change in plasma levels of Aβ1-42 after solanezumab infusion
Measured: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
Mean change in plasma levels of Aβ1-40 species after solanezumab infusion
Measured: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
Mean change in plasma levels of modified Aβ species after solanezumab infusion
Measured: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
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 Eli Lilly and CompanyThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148498
- Sponsor's protocol ID
- 13572
- Other IDs
- H8A-MC-LZAT
- Status last verified
- Aug 2012
- First submitted
- 18 Jun 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Amyloid Beta Species After a Single Solanezumab Infusion in Nondemented Individuals and Those With Mild Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT01148498
- Acronym / sponsor ID
- 13572
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Jun 2010 (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 trial is to compare the average change in the amount of amyloid beta species in blood after an infusion of solanezumab.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: solanezumabOlder adults with mild Dementia Alzheimer's Type (DAT) |
| Group 2 | Experimental | Drug: solanezumabOlder adult controls with possible Alzheimer's Disease Pathology |
| Group 3 | Experimental | Drug: solanezumabOlder adult controls with no evidence of Alzheimer's Disease |
| Group 4 | Experimental | Drug: solanezumabYounger subjects who are assumed to have no cognitive impairment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals in Groups 1, 2, and 3, described below, will be participants in the longitudinal studies of memory and aging at the Washington University Alzheimer's Disease Research Center (WU-ADRC). These participants must have results from apolipoprotein E (ApoE) genotyping from the WU-ADRC. At the beginning of the study they must be between 45 and 90 years of age and if a female of childbearing potential, not be breastfeeding, test negative for pregnancy, and be using a medically accepted form of birth control at the time of the infusion and for 6 months afterward. Subjects must also meet the criteria below for each study group
- Have mild DAT, as determined by Clinical Dementia Rating (CDR) of 0.5 or 1
- Have florbetapir PET imaging findings consistent with underlying AD pathology.
- Have no cognitive impairment as indicated by a CDR rating of 0. Have possible AD pathology, as determined by florbetapir PET imaging.
- Have no cognitive impairment as indicated by a CDR rating of 0. Have no evidence of AD pathology as determined by florbetapir PET imaging.
Key exclusion criteria (11 listed)
- Have previously completed or withdrawn from this study or any other study investigating solanezumab
- Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
- Has allergies to humanized monoclonal antibodies
- Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- Has a history of chronic alcohol or drug abuse/dependence
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 |
|---|---|---|
| solanezumabAlso: LY2062430, A Beta Antibody400mg administered once intravenously | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)
Time frame: Baseline up to 112 days post drug administration
3 secondary outcomes
Mean change in plasma levels of Aβ1-42 after solanezumab infusion
Time frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
Mean change in plasma levels of Aβ1-40 species after solanezumab infusion
Time frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
Mean change in plasma levels of modified Aβ species after solanezumab infusion
Time frame: Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose
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 25 Sep 2012.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 1 site in United States.
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 11 inclusion and 11 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 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3) (time frame: Baseline up to 112 days post drug administration). 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 25 Sep 2012.