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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00904683
Registration number
NCT00904683
Ethics application status
Date submitted
18/05/2009
Date registered
20/05/2009
Date last updated
13/12/2012
Titles & IDs
Public title
Effect of LY2062430 on the Progression of Alzheimer's Disease
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Scientific title
Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
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Secondary ID [1]
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H8A-MC-LZAN
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Secondary ID [2]
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11934
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Universal Trial Number (UTN)
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Trial acronym
EXPEDITION2
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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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0
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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 - LY2062430
Treatment: Drugs - Placebo
Experimental: LY2062430 -
Placebo comparator: Placebo -
Treatment: Drugs: LY2062430
400 mg intravenously (IV) every 4 weeks for 80 weeks
Treatment: Drugs: Placebo
intravenously (IV) every 4 weeks for 80 weeks
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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 to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
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Assessment method [1]
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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 to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
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Assessment method [1]
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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 to Week 80 in Neuropsychiatric Inventory (NPI) Score
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Assessment method [2]
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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 to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)
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Assessment method [3]
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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 to Week 80 in Mini-Mental State Examination (MMSE) Score
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Assessment method [4]
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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 to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score
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Assessment method [5]
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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 to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score
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Assessment method [6]
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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 to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score
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Assessment method [7]
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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 to Week 80 in Plasma Amyloid Beta Levels
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Assessment method [8]
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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 to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item and 12-Item Scale (ADAS-Cog11 and ADAS-Cog12)
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Assessment method [9]
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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 to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score
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Assessment method [10]
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Timepoint [10]
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Baseline, Week 80
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Eligibility
Key inclusion criteria
* Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
* If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization
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Minimum age
55
Years
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Maximum age
No limit
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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
* Has serious or unstable illness(es)
* Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
* Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
* Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
* Has allergies to humanized monoclonal antibodies
* Chronic alcohol and/or drug abuse within the past 5 years
* Has any contraindications for MRI studies
* Requires treatment with another monoclonal antibody
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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
Completed
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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
1/05/2009
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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
1/06/2012
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Sample size
Target
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Accrual to date
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Final
1040
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,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. - Bankstown
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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. - Darlinghurst
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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. - Gosford
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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. - Kogarah
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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. - Chermside
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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. - Toowoomba
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Recruitment hospital [7]
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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 [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. - Glen Iris
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Recruitment hospital [9]
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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 Heights
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Recruitment hospital [10]
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. - Melbourne
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Recruitment hospital [11]
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
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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4650 - Toowoomba
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3146 - Glen Iris
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Recruitment postcode(s) [9]
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3081 - Heidelberg Heights
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Recruitment postcode(s) [10]
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3004 - Melbourne
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Recruitment postcode(s) [11]
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6008 - Subiaco
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Recruitment outside Australia
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Cassino
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Incheon
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Wiltshire
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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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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD. LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.
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Trial website
https://clinicaltrials.gov/study/NCT00904683
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Trial related presentations / publications
Reed C, Belger M, Dell'Agnello G, Kahle-Wrobleski K, Sethuraman G, Hake A, Raskin J, Henley D. Representativeness of European clinical trial populations in mild Alzheimer's disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study. Alzheimers Res Ther. 2018 Apr 3;10(1):36. doi: 10.1186/s13195-018-0360-4. Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508. Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015. Liu-Seifert H, Siemers E, Sundell K, Price K, Han B, Selzler K, Aisen P, Cummings J, Raskin J, Mohs R. Cognitive and functional decline and their relationship in patients with mild Alzheimer's dementia. J Alzheimers Dis. 2015;43(3):949-55. doi: 10.3233/JAD-140792. Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.
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Public notes
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Contacts
Principal investigator
Name
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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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Address
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Eli Lilly and Company
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https://clinicaltrials.gov/study/NCT00904683
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