Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01900665
Registration number
NCT01900665
Ethics application status
Date submitted
12/07/2013
Date registered
16/07/2013
Titles & IDs
Public title
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
Query!
Scientific title
Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
Query!
Secondary ID [1]
0
0
H8A-MC-LZAX
Query!
Secondary ID [2]
0
0
15136
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EXPEDITION 3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Alzheimer's disease
Query!
Neurological
0
0
0
0
Query!
Dementias
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Solanezumab
Treatment: Drugs - Placebo
Experimental: Solanezumab - Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Placebo comparator: Placebo - Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
Treatment: Drugs: Solanezumab
Administered Intravenously (IV)
Treatment: Drugs: Placebo
Administered IV
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
Query!
Assessment method [1]
0
0
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [1]
0
0
Baseline, Week 80
Query!
Secondary outcome [1]
0
0
Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
Query!
Assessment method [1]
0
0
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [1]
0
0
Baseline, Week 80
Query!
Secondary outcome [2]
0
0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
Query!
Assessment method [2]
0
0
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [2]
0
0
Baseline, Week 80
Query!
Secondary outcome [3]
0
0
Change From Baseline in Mini-Mental State Examination (MMSE)
Query!
Assessment method [3]
0
0
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) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [3]
0
0
Baseline, Week 80
Query!
Secondary outcome [4]
0
0
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
Query!
Assessment method [4]
0
0
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [4]
0
0
Baseline, Week 80
Query!
Secondary outcome [5]
0
0
Change From Baseline in Functional Activities Questionnaire (FAQ)
Query!
Assessment method [5]
0
0
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [5]
0
0
Baseline, Week 80
Query!
Secondary outcome [6]
0
0
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Query!
Assessment method [6]
0
0
CDR-SB 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 (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [6]
0
0
Baseline, Week 80
Query!
Secondary outcome [7]
0
0
Change From Baseline in Neuropsychiatric Inventory (NPI)
Query!
Assessment method [7]
0
0
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [7]
0
0
Baseline, Week 80
Query!
Secondary outcome [8]
0
0
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)
Query!
Assessment method [8]
0
0
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [8]
0
0
Baseline, Week 80
Query!
Secondary outcome [9]
0
0
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)
Query!
Assessment method [9]
0
0
Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [9]
0
0
Baseline, Week 80
Query!
Secondary outcome [10]
0
0
Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)
Query!
Assessment method [10]
0
0
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [10]
0
0
Baseline, Week 80
Query!
Secondary outcome [11]
0
0
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
Query!
Assessment method [11]
0
0
Integrated Alzheimer's Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [11]
0
0
Baseline, Week 80
Query!
Secondary outcome [12]
0
0
Percentage of Participants of Cognitive and Functional Responders
Query!
Assessment method [12]
0
0
Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline. A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.
Query!
Timepoint [12]
0
0
Baseline through Week 80
Query!
Secondary outcome [13]
0
0
Change From Baseline in Plasma Amyloid-Beta (Aß) Species
Query!
Assessment method [13]
0
0
Concentration of amino acid peptide known as Aß 1-42 in plasma. The change in plasma Aß analytes after treatment were assessed separately for each plasma Aß parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [13]
0
0
Baseline, Week 80
Query!
Secondary outcome [14]
0
0
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
Query!
Assessment method [14]
0
0
The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [14]
0
0
Baseline, Week 80
Query!
Secondary outcome [15]
0
0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)
Query!
Assessment method [15]
0
0
Area Under the Concentration versus Time Curve was evaluated for Solanezumab.
Query!
Timepoint [15]
0
0
Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion
Query!
Secondary outcome [16]
0
0
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan
Query!
Assessment method [16]
0
0
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
Query!
Timepoint [16]
0
0
Baseline, Week 80
Query!
Secondary outcome [17]
0
0
Change From Baseline in Cerebrospinal Fluid (CSF) Aß Levels
Query!
Assessment method [17]
0
0
Concentration of CSF parameters includes amino acid peptide known as Aß 1-42 and Aß 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Query!
Timepoint [17]
0
0
Baseline, Week 80
Query!
Eligibility
Key inclusion criteria
* Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
* Has a Modified Hachinski Ischemia Scale score of less than or equal to 4
* Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit
* Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)
* Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD
* Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
90
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
* Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years
* Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
* Has a history within the last 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 posttreatment
* Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
* Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks
* Has a history of chronic alcohol or drug abuse/dependence within the past 5 years
* Has a Visit 1 MRI with results showing >4 Amyloid-related Imaging Abnormality (ARIA), -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2129
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
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. - Darlinghurst
Query!
Recruitment hospital [2]
0
0
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. - East Gosford
Query!
Recruitment hospital [3]
0
0
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. - Kogarah
Query!
Recruitment hospital [4]
0
0
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. - Box Hill
Query!
Recruitment hospital [5]
0
0
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. - Caulfield
Query!
Recruitment hospital [6]
0
0
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. - Fitzroy
Query!
Recruitment hospital [7]
0
0
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. - Heidelberg
Query!
Recruitment hospital [8]
0
0
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. - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2250 - East Gosford
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3162 - Caulfield
Query!
Recruitment postcode(s) [6]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [7]
0
0
3081 - Heidelberg
Query!
Recruitment postcode(s) [8]
0
0
06008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maine
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maryland
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Massachusetts
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Michigan
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nebraska
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nevada
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Jersey
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Mexico
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oklahoma
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oregon
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Pennsylvania
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Rhode Island
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Carolina
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
South Dakota
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Tennessee
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Texas
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Utah
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Vermont
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Virginia
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Washington
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ontario
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Bron
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Dijon
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Lille
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Marseille
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Montpellier
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Paris
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Reims
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Rennes
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Strasbourg
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Toulouse
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Villeurbanne
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Berlin
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Boeblingen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Hannover
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Mannheim
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Munich
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Siegen
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Ulm
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Westerstede
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Firenze
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Genova
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Milano
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Pisa
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Ponderano (BI)
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Rome
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Torino
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Aichi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Hyogo
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Ibaraki
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Kanagawa
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Kobe
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Kyoto
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Osaka
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Shizuoka
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Tokushima
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Tokyo
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Bydgoszcz
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Katowice
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Krakow
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Sopot
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Szczecin
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Warsaw
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barakaldo
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Barcelona
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Getafe
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Guipuzcoa
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Madrid
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Plasencia
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Salt-Girona
Query!
Country [89]
0
0
Sweden
Query!
State/province [89]
0
0
Jönköping
Query!
Country [90]
0
0
Sweden
Query!
State/province [90]
0
0
Malmo
Query!
Country [91]
0
0
Sweden
Query!
State/province [91]
0
0
Molndal
Query!
Country [92]
0
0
Sweden
Query!
State/province [92]
0
0
Stockholm
Query!
Country [93]
0
0
Sweden
Query!
State/province [93]
0
0
Umea
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Avon
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Devon
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
East Sussex
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Glasgow
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
London
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Manchester
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Wiltshire
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Newcastle
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01900665
Query!
Trial related presentations / publications
Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01900665