Alzheimer's DiseasePhase 1NCT01459016
A Non-drug Methods Study in Participants With Alzheimer's Disease
A Phase 1 study testing PET scan using florbetapir and MRI Scan in people with Alzheimer's Disease, run by Eli Lilly and Company at 16 sites in France.
Trial summary
This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PET scan using florbetapir and MRI Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 16 sitesFrance
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with prodromal Alzheimer's Disease (AD) or mild AD based on the disease diagnostic criteria
- Are men or post-menopausal women, at least 55 years of age. Post-menopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years
- Have a caretaker/study informant who provides a separate written informed consent to participate. If a caretaker/study informant cannot continue, one replacement is allowed
- Gradual and progressive change in memory function reported by participants or informants over more than 6 months
- Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test (FCSRT): less than or equal to (≤) 16 for free recall or ≤ 40 for total recall. Protocol amendment: FCSRT ≤ 24 for free recall or ≤ 44 for total recall
- Clinical Dementia Rating (CDR) equals 0.5 or 1, Memory box score greater than or equal to 0.5
Show all 9Show fewer
- Mini Mental Scale Examination (MMSE) 20-30. Protocol amendment: MMSE 23-30, inclusive
- Positive florbetapir F 18 scan
- Participants must meet all of the Disease Diagnostic Criteria to be considered for enrollment
Who cannot join
- Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders
- Frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's Disease or concomitant Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
- Has B12 <200 pg/L or folate <7.5 nmol/L indicating vitamin deficiency
- Has a history within the past 5 years of a serious infectious disease affecting the brain, including meningitis, or encephalitis
- Significant history of alcoholism or substance abuse (at the judgment of the investigator)
- Severe or recurrent head injury that is clinically relevant to the disease under study, (that is, with permanent neurological/cognitive sequelae)
Show all 32Show fewer
- Onset of dementia following heart surgery or cardiac arrest
- Diagnosis or history of cerebrovascular disease (for example, stroke, transient ischemic attack), severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage, or subdural hematoma that could contribute to the subject's current cognitive or functional status, impair ability to fully participate in the trial or that may impact status
- Has had a Positron Emission Tomography (PET) within 6 months of the scheduled imaging follow-up
- Greater than 4 cerebral microhemorrhages (CMH) on T2* -weighted gradient-recalled echo sequences (regardless of their anatomical or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, or prior evidence of macrohemorrhage
- Any indications of severe deep white matter lesions or vasogenic edema that present as hyperintense regions on the Fluid Attenuated Inversion Recovery (FLAIR) sequence, or other clinically relevant findings observed on the Magnetic Resonance Imaging (MRI) scans
- Specific exclusionary brain MRI findings, as determined by the investigator in consultation with the sponsor, that could either contribute to the participant's current cognitive or functional decline impair ability to fully participate in the trial or that may impact status during the trial (for example, brain tumors or other non-vascular structural abnormalities like hydrocephalus)
- History within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection
- History of clinically significant cardiovascular or renal events
- Diastolic blood pressure of 95 or more and systolic blood pressure of 160 or more in sitting position after at least 5 minutes of rest
- Any history of seizure
- History of clinically significant head trauma or clinically significant unexplained loss of consciousness within the last 5 years (as determined by the investigator in consultation with the Sponsor)
- A current Axis I diagnosis of major depressive disorder or other psychiatric illness (Diagnostic and Statistical Manual Revised Fourth Edition [DSM-IV-TR]) criteria per the investigator's judgment. (Note: Participants on a stable antidepressant and/or anxiolytic treatment may participate.)
- Having suicidal ideations, or attempted suicide in the past 15 years
- History of schizophrenia, bipolar disorder, or other severe mental illness
- Known history of alcohol or drug abuse (as defined by the DSM-IV-TR) within 5 years prior to enrolling or a positive result regarding use of illicit drugs on the drug screening test
- Chronic hepatic diseases as indicated by liver function test abnormalities (alanine trasaminase [ALT], aspartate transaminase [AST], bilirubin, or gamma-glutamyl transferase [GGT] above 2 times upper limit of normal), positive serology for Hepatitis B or C, or other manifestations of liver disease
- Has compromised renal function at screening, as determined by creatinine clearance <30 mL/min based on Cockcroft-Gault calculation of creatinine clearance
- History of asthma, chronic obstructive pulmonary disease, or other chronic respiratory conditions
- Known positive human immunodeficiency virus (HIV) status, history of syphilitic infection
- A clinically significant abnormality in the 12-lead electrocardiograms (ECG), including complete heart block, bradycardia (heart rate <50 beats/minute), tachycardia (heart rate ≥95 beats/minute), sinus pauses >2 seconds, second or third degree heart block, QTc >450 msec for males or QTc >470 for females
- Treatment with an investigational small molecule within 1 year preceding the first study period, or participation in a trial with active or passive immunization against amyloid if participant was assigned to the active treatment arm
- Fulfillment of any contraindications to a 3T magnetic resonance imaging (MRI) scan (for example, subjects with non-removable ferromagnetic implants (such as cardiac pacemaker), aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan)
- Sensitivity to florbetapir F 18
- Are not capable of swallowing whole oral medications
- Abnormal thyroid function
- Thyroid stimulating hormone (TSH) values are outside of the normal range 0.3-5.6 mIU/L. (NOTE: Participants with stable treatment of hypothyroidism and with normal value of TSH will be allowed to enter the study)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
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.
Cahors, 46005
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Castres, 81108
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Foix, 09017
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Lavaur, BP85 81502
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Léon, 33076
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Lille, 59037
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.
Limoges, 87042
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Marseille, 13385
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Montauban, 82013
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Nancy, 54511
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Paris, 75651
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.
Rennes, 35000
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.
Strasbourg, 67091
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Toulouse, 31059
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Tours, 37044
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.
Vic-en-Bigorre, 65500
About this study
Official title: An Exploratory Study of Brain Imaging Biomarkers in Patients With Alzheimer's Pathology Receiving Standard of Care
This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology.
Read the detailed description
After trial initiation, the protocol was amended to extend the single observation time period (6 to 9 months) to two time points (6 and 12 months), and to focus on prodromal AD (Mini-Mental State Examination [MMSE] 23-30 inclusive, Free and Cued Selective Reminding Test [FCSRT] less than or equal to [≤] 24 for free recall or ≤ 44 for total recall). Participants enrolled under the original protocol were allowed to continue in the extension study if they so desired, and if they met the new inclusion criteria. Due to the number of participants that completed the extended trial, no sub-group analysis was performed based on which amendment the participants entered under.
- Conditions
- Alzheimer's Disease
- Being tested
- PET scan using florbetapir, MRI Scan
- Keywords
- Mild Cognitive Impairment, Brain Imaging Biomarkers, Magnetic resonance imaging biomarker, Positron Emission Tomography
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan using florbetapirOther
Also called AV-45
A single intravenous microdose of 260 MBq (7 mCi) 18F-AV-45 (florbetapir F 18) will be administered.
MRI ScanOther
Three different measurements will be taken: volumetric MRI (vMRI), diffusion tensor imaging (DTI), and resting state functional MRI (rsfMRI). In addition, radiological MRI scans will be taken to monitor vasogenic edema and microhemorrhages.
| Study group | Role | What they receive |
|---|---|---|
| Imaging Biomarkers | Experimental | Not described Receives: Other: PET scan using florbetapir; Other: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)
Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Secondary outcomes (6)
Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir
Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.
Measured: Baseline
Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)
Measured: Baseline
Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Mini Mental State Examination (MMSE) Total Score
The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score
The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Clinical Dementia Rating (CDR) Total Score
The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.
Measured: Baseline, 6 Mos; Baseline, 12 Mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
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
- NCT01459016
- Sponsor's protocol ID
- 14162
- Other IDs
- I4O-MC-BACH
- Status last verified
- May 2018
- First submitted
- 12 Oct 2011
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Brain Imaging Biomarkers in Patients With Alzheimer's Pathology Receiving Standard of Care
- ClinicalTrials.gov ID
- NCT01459016
- Acronym / sponsor ID
- 14162
- Conditions
- Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, Brain Imaging Biomarkers, Magnetic resonance imaging biomarker, Positron Emission Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology.
Detailed description
After trial initiation, the protocol was amended to extend the single observation time period (6 to 9 months) to two time points (6 and 12 months), and to focus on prodromal AD (Mini-Mental State Examination [MMSE] 23-30 inclusive, Free and Cued Selective Reminding Test [FCSRT] less than or equal to [≤] 24 for free recall or ≤ 44 for total recall). Participants enrolled under the original protocol were allowed to continue in the extension study if they so desired, and if they met the new inclusion criteria. Due to the number of participants that completed the extended trial, no sub-group analysis was performed based on which amendment the participants entered under.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging Biomarkers | Experimental | Other: PET scan using florbetapir, Other: MRI Scan |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Present with prodromal Alzheimer's Disease (AD) or mild AD based on the disease diagnostic criteria
- Are men or post-menopausal women, at least 55 years of age. Post-menopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years
- Have a caretaker/study informant who provides a separate written informed consent to participate. If a caretaker/study informant cannot continue, one replacement is allowed
- Gradual and progressive change in memory function reported by participants or informants over more than 6 months
- Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test (FCSRT): less than or equal to (≤) 16 for free recall or ≤ 40 for total recall. Protocol amendment: FCSRT ≤ 24 for free recall or ≤ 44 for total recall
Key exclusion criteria (32 listed)
- Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders
- Frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's Disease or concomitant Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
- Has B12 <200 pg/L or folate <7.5 nmol/L indicating vitamin deficiency
- Has a history within the past 5 years of a serious infectious disease affecting the brain, including meningitis, or encephalitis
- Significant history of alcoholism or substance abuse (at the judgment of the investigator)
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 |
|---|---|---|
| PET scan using florbetapirAlso: AV-45A single intravenous microdose of 260 MBq (7 mCi) 18F-AV-45 (florbetapir F 18) will be administered. | Other | Imaging Biomarkers |
| MRI ScanThree different measurements will be taken: volumetric MRI (vMRI), diffusion tensor imaging (DTI), and resting state functional MRI (rsfMRI). In addition, radiological MRI scans will be taken to monitor vasogenic edema and microhemorrhages. | Other | Imaging Biomarkers |
Primary outcome
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.
Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.
Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.
6 secondary outcomes
Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir
Time frame: Baseline
Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)
Time frame: Baseline
Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Mini Mental State Examination (MMSE) Total Score
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Change From Baseline in the Clinical Dementia Rating (CDR) Total Score
Time frame: Baseline, 6 Mos; Baseline, 12 Mos
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET scan using florbetapir and MRI Scan in people with Alzheimer's Disease, run by Eli Lilly and Company at 16 sites in France.
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 32 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 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI) (time frame: Baseline, 6 Mos; Baseline, 12 Mos). The study lists 5 primary outcomes in all. 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 28 Jun 2018.