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/NCT01127633




Registration number
NCT01127633
Ethics application status
Date submitted
19/05/2010
Date registered
21/05/2010
Date last updated
8/10/2019

Titles & IDs
Public title
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
Scientific title
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid ß Antibody in Patients With Alzheimer's Disease
Secondary ID [1] 0 0
H8A-MC-LZAO
Secondary ID [2] 0 0
11935
Universal Trial Number (UTN)
Trial acronym
EXPEDITION EXT
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 - Solanezumab
Treatment: Drugs - Placebo

Experimental: Solanezumab -

Placebo comparator: Placebo -


Treatment: Drugs: Solanezumab
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.

Treatment: Drugs: Placebo
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Timepoint [1] 0 0
Baseline through Week 104
Secondary outcome [1] 0 0
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
Timepoint [1] 0 0
Baseline, Week 104
Secondary outcome [2] 0 0
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Timepoint [2] 0 0
Baseline, Week 104
Secondary outcome [3] 0 0
Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Timepoint [3] 0 0
Baseline, Week 104
Secondary outcome [4] 0 0
Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
Timepoint [4] 0 0
Baseline, Week 104
Secondary outcome [5] 0 0
Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
Timepoint [5] 0 0
Baseline, Week 104
Secondary outcome [6] 0 0
Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
Timepoint [6] 0 0
Baseline, Week 104
Secondary outcome [7] 0 0
Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Timepoint [7] 0 0
Baseline, Week 104
Secondary outcome [8] 0 0
Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
Timepoint [8] 0 0
Baseline, Week 104
Secondary outcome [9] 0 0
Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aß) Levels
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
Timepoint [10] 0 0
Baseline, Week 104
Secondary outcome [11] 0 0
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
Timepoint [11] 0 0
Baseline, Week 104
Secondary outcome [12] 0 0
Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease
Timepoint [12] 0 0
Baseline, Week 104

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 Alzheimer's Disease
* Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
* Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
* Must have good vein access to administer infusions
* Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
Accrual to date
Final
1457
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. - Gosford
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. - Kogarah
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. - Chermside
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. - Toowoomba
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. - Box Hill
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. - Glen Iris
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 Heights
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. - Melbourne
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. - Subiaco
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4650 - Toowoomba
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3146 - Glen Iris
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Vermont
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
Argentina
State/province [30] 0 0
Buenos Aires
Country [31] 0 0
Argentina
State/province [31] 0 0
Ciudad Automona De Buenos Aire
Country [32] 0 0
Argentina
State/province [32] 0 0
Cordoba
Country [33] 0 0
Argentina
State/province [33] 0 0
Mendoza
Country [34] 0 0
Argentina
State/province [34] 0 0
Rosario
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Brazil
State/province [36] 0 0
Curitiba
Country [37] 0 0
Brazil
State/province [37] 0 0
Itapira
Country [38] 0 0
Brazil
State/province [38] 0 0
Porto Alegre
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio De Janeiro
Country [40] 0 0
Brazil
State/province [40] 0 0
São Paulo
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
France
State/province [46] 0 0
Rennes
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg
Country [48] 0 0
France
State/province [48] 0 0
Toulouse
Country [49] 0 0
Germany
State/province [49] 0 0
Berlin
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Mannheim
Country [53] 0 0
Germany
State/province [53] 0 0
Munich
Country [54] 0 0
Germany
State/province [54] 0 0
Regensburg
Country [55] 0 0
Italy
State/province [55] 0 0
Baggiovara
Country [56] 0 0
Italy
State/province [56] 0 0
Biella
Country [57] 0 0
Italy
State/province [57] 0 0
Chieti
Country [58] 0 0
Italy
State/province [58] 0 0
Genova
Country [59] 0 0
Italy
State/province [59] 0 0
Lido Di Camaiore
Country [60] 0 0
Italy
State/province [60] 0 0
Milano
Country [61] 0 0
Italy
State/province [61] 0 0
Rome
Country [62] 0 0
Japan
State/province [62] 0 0
Aichi
Country [63] 0 0
Japan
State/province [63] 0 0
Ehime
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Hiroshima
Country [66] 0 0
Japan
State/province [66] 0 0
Hyogo
Country [67] 0 0
Japan
State/province [67] 0 0
Kanagawa
Country [68] 0 0
Japan
State/province [68] 0 0
Kyoto
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Shizuoka
Country [71] 0 0
Japan
State/province [71] 0 0
Tokyo
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Incheon
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Seongnam-Si
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Suwon-Si
Country [76] 0 0
Poland
State/province [76] 0 0
Bydgoszcz
Country [77] 0 0
Poland
State/province [77] 0 0
Gliwice
Country [78] 0 0
Poland
State/province [78] 0 0
Katowice
Country [79] 0 0
Poland
State/province [79] 0 0
Krakow
Country [80] 0 0
Poland
State/province [80] 0 0
Lublin
Country [81] 0 0
Poland
State/province [81] 0 0
Warsaw
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Chelyabinsk
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Saint Petersburg
Country [84] 0 0
Spain
State/province [84] 0 0
Barcelona
Country [85] 0 0
Spain
State/province [85] 0 0
Getafe
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Spain
State/province [87] 0 0
Plasencia
Country [88] 0 0
Spain
State/province [88] 0 0
Terrassa
Country [89] 0 0
Sweden
State/province [89] 0 0
Jönköping
Country [90] 0 0
Sweden
State/province [90] 0 0
Kalmar
Country [91] 0 0
Sweden
State/province [91] 0 0
Lund
Country [92] 0 0
Sweden
State/province [92] 0 0
Molndal
Country [93] 0 0
Sweden
State/province [93] 0 0
Umea
Country [94] 0 0
Taiwan
State/province [94] 0 0
Guishan
Country [95] 0 0
Taiwan
State/province [95] 0 0
Niaosong
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taipei
Country [97] 0 0
United Kingdom
State/province [97] 0 0
E Susx
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Glasgow
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).
Trial website
https://clinicaltrials.gov/study/NCT01127633
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01127633