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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
Scientific title
Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
Secondary ID [1] 0 0
H8A-MC-LZAN
Secondary ID [2] 0 0
11934
Universal Trial Number (UTN)
Trial acronym
EXPEDITION2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
Timepoint [1] 0 0
Baseline, Week 80
Secondary outcome [1] 0 0
Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Timepoint [1] 0 0
Baseline, Week 80
Secondary outcome [2] 0 0
Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [3] 0 0
Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)
Timepoint [3] 0 0
Baseline, Week 80
Secondary outcome [4] 0 0
Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score
Timepoint [4] 0 0
Baseline, Week 80
Secondary outcome [5] 0 0
Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score
Timepoint [5] 0 0
Baseline, Week 80
Secondary outcome [6] 0 0
Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score
Timepoint [6] 0 0
Baseline, Week 80
Secondary outcome [7] 0 0
Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score
Timepoint [7] 0 0
Baseline, Week 80
Secondary outcome [8] 0 0
Change from Baseline to Week 80 in Plasma Amyloid Beta Levels
Timepoint [8] 0 0
Baseline, Week 80
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Baseline, Week 80
Secondary outcome [10] 0 0
Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score
Timepoint [10] 0 0
Baseline, Week 80

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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
1040
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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. - Bankstown
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. - Darlinghurst
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. - Gosford
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. - Kogarah
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. - Chermside
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. - Toowoomba
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. - Box Hill
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. - Glen Iris
Recruitment hospital [9] 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 Heights
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
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
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4650 - Toowoomba
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3146 - Glen Iris
Recruitment postcode(s) [9] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
France
State/province [11] 0 0
Aix En Provence
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Strasbourg
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Hannover
Country [19] 0 0
Germany
State/province [19] 0 0
Mannheim
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Germany
State/province [20] 0 0
Marburg
Country [21] 0 0
Germany
State/province [21] 0 0
Munchen
Country [22] 0 0
Germany
State/province [22] 0 0
München
Country [23] 0 0
Germany
State/province [23] 0 0
Regensburg
Country [24] 0 0
Italy
State/province [24] 0 0
Biella
Country [25] 0 0
Italy
State/province [25] 0 0
Boggiovara
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Italy
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Cassino
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Italy
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Chieti
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Italy
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Genova
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Italy
State/province [29] 0 0
Lido Di Camaiore
Country [30] 0 0
Italy
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Milano
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Italy
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Rome
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-Si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Poland
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Bialystok
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Bydgoszcz
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Gliwice
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Katowice
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Krakow
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Lublin
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Warsaw
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Rostov-On-Don
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Saint Petersburg
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Barcelona
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Getafe
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Madrid
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Plasencia
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Spain
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Terrassa
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Sweden
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Joenkoeping
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Sweden
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Kalmar
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Sweden
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Lund
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Sweden
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Malmo
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Molndal
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Stockholm
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Sweden
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Umea
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Taiwan
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Kaohsiung
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Taiwan
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Niao Sung Hsiang
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Taichung
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Taipei
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Taiwan
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Tao-Yuan
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Taiwan
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Yung-Kang, Tainan
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United Kingdom
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E Susx
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United Kingdom
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Glasgow
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United Kingdom
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Greater London
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London
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United Kingdom
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Syorks
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United Kingdom
State/province [78] 0 0
Wiltshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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 not provided in https://clinicaltrials.gov/study/NCT00904683