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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01900665
Registration number
NCT01900665
Ethics application status
Date submitted
12/07/2013
Date registered
16/07/2013
Date last updated
9/10/2019
Titles & IDs
Public title
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
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Scientific title
Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
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Secondary ID [1]
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H8A-MC-LZAX
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Secondary ID [2]
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15136
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Universal Trial Number (UTN)
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Trial acronym
EXPEDITION 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 80
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Secondary outcome [1]
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Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 80
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Secondary outcome [2]
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 80
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Secondary outcome [3]
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Change From Baseline in Mini-Mental State Examination (MMSE)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 80
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Secondary outcome [4]
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Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 80
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Secondary outcome [5]
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Change From Baseline in Functional Activities Questionnaire (FAQ)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 80
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Secondary outcome [6]
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Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 80
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Secondary outcome [7]
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Change From Baseline in Neuropsychiatric Inventory (NPI)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 80
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Secondary outcome [8]
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Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Week 80
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Secondary outcome [9]
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Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 80
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Secondary outcome [10]
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Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Week 80
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Secondary outcome [11]
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Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 80
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Secondary outcome [12]
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Percentage of Participants of Cognitive and Functional Responders
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline through Week 80
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Secondary outcome [13]
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Change From Baseline in Plasma Amyloid-Beta (Aß) Species
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Week 80
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Secondary outcome [14]
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Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, Week 80
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Secondary outcome [15]
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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)
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Assessment method [15]
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Area Under the Concentration versus Time Curve was evaluated for Solanezumab.
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Timepoint [15]
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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
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Secondary outcome [16]
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Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Week 80
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Secondary outcome [17]
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Change From Baseline in Cerebrospinal Fluid (CSF) Aß Levels
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Week 80
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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
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Minimum age
55
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2017
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Sample size
Target
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Accrual to date
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Final
2129
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment hospital [5]
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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
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Recruitment hospital [6]
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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
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Recruitment hospital [7]
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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
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Recruitment hospital [8]
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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
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2250 - East Gosford
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2217 - Kogarah
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Recruitment postcode(s) [4]
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3128 - Box Hill
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3162 - Caulfield
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3081 - Heidelberg
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Recruitment postcode(s) [8]
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06008 - Subiaco
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01900665
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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)
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01900665
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