Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
Country [20] 0 0
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
Country [26] 0 0
Italy
State/province [26] 0 0
Cassino
Country [27] 0 0
Italy
State/province [27] 0 0
Chieti
Country [28] 0 0
Italy
State/province [28] 0 0
Genova
Country [29] 0 0
Italy
State/province [29] 0 0
Lido Di Camaiore
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Rome
Country [32] 0 0
Japan
State/province [32] 0 0
Ehime
Country [33] 0 0
Japan
State/province [33] 0 0
Fukuoka
Country [34] 0 0
Japan
State/province [34] 0 0
Hyogo
Country [35] 0 0
Japan
State/province [35] 0 0
Kanagawa
Country [36] 0 0
Japan
State/province [36] 0 0
Kyoto
Country [37] 0 0
Japan
State/province [37] 0 0
Osaka
Country [38] 0 0
Japan
State/province [38] 0 0
Shizuoka
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Incheon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seongnam-Si
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Suwon
Country [44] 0 0
Poland
State/province [44] 0 0
Bialystok
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Gliwice
Country [47] 0 0
Poland
State/province [47] 0 0
Katowice
Country [48] 0 0
Poland
State/province [48] 0 0
Krakow
Country [49] 0 0
Poland
State/province [49] 0 0
Lublin
Country [50] 0 0
Poland
State/province [50] 0 0
Warsaw
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Chelyabinsk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Ekaterinburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Rostov-On-Don
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Saint Petersburg
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Getafe
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Plasencia
Country [59] 0 0
Spain
State/province [59] 0 0
Terrassa
Country [60] 0 0
Sweden
State/province [60] 0 0
Joenkoeping
Country [61] 0 0
Sweden
State/province [61] 0 0
Kalmar
Country [62] 0 0
Sweden
State/province [62] 0 0
Lund
Country [63] 0 0
Sweden
State/province [63] 0 0
Malmo
Country [64] 0 0
Sweden
State/province [64] 0 0
Molndal
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Sweden
State/province [66] 0 0
Umea
Country [67] 0 0
Taiwan
State/province [67] 0 0
Kaohsiung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Niao Sung Hsiang
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Taiwan
State/province [71] 0 0
Tao-Yuan
Country [72] 0 0
Taiwan
State/province [72] 0 0
Yung-Kang, Tainan
Country [73] 0 0
United Kingdom
State/province [73] 0 0
E Susx
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Glasgow
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Greater London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Syorks
Country [78] 0 0
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
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.
Trial website
https://clinicaltrials.gov/study/NCT00904683
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00904683