Alzheimer's DiseasePhase 3EXPEDITION EXTNCT01127633
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
A Phase 3 study testing Solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 147 sites in 16 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Solanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,457 participants
- Where
- 147 sitesin 16 countries
- Study dates
- Dec 2010to Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
147 sites in 16 countries.
147 sites in 16 countries
United States64 sites
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Albany, New York, 12205
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Albuquerque, New Mexico, 87109
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Amherst, New York, 14226
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Atlanta, Georgia, 30341
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Baltimore, Maryland, 21285
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Beachwood, Ohio, 44122
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Belmont, Massachusetts, 02478
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Bennington, Vermont, 05201
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Boca Raton, Florida, 33431
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Brooklyn, New York, 11235
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Burlington, Vermont, 05401
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Canton, Georgia, 30114
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Carson, California, 90746
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Charleston, South Carolina, 29425
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Creve Coeur, Missouri, 63141
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Decatur, Georgia, 30033
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Denver, Colorado, 80239
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East Providence, Rhode Island, 02914
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Eugene, Oregon, 97401
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Fairfield, Connecticut, 06824
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Fort Myers, Florida, 33912
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Greer, South Carolina, 29650
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Hamden, Connecticut, 06518
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Hollywood, Florida, 33021
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Indianapolis, Indiana, 46202
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Laguna Hills, California, 92653
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Latham, New York, 12210
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Lexington, Kentucky, 40503
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Little Rock, Arkansas, 72211
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Lomita, California, 90717
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Los Angeles, California, 90073
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Miami, Florida, 33137
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Miami Springs, Florida, 33166
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New Haven, Connecticut, 06510
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New York, New York, 10032
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Newark, Delaware, 19713
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Norfolk, Virginia, 23502
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Norwalk, Connecticut, 06851
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Oklahoma City, Oklahoma, 73116
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Orange City, Florida, 32763
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Orlando, Florida, 32806
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Oxnard, California, 93030
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Philadelphia, Pennsylvania, 19104
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Phoenix, Arizona, 85006
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Portland, Oregon, 97210
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Raleigh, North Carolina, 27607
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Roanoke, Virginia, 24018
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Rockville, Maryland, 20852
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Salt Lake City, Utah, 84108
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San Diego, California, 92103
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San Francisco, California, 94109
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Santa Ana, California, 92705
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Santa Monica, California, 90404
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Seattle, Washington, 98108
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Sioux Falls, South Dakota, 57105
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Staten Island, New York, 10312
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Sun City, Arizona, 85351
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Sunrise, Florida, 33351
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Tampa, Florida, 33613
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Toledo, Ohio, 43623
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Traverse City, Michigan, 49684
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Tucson, Arizona, 85718
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Washington D.C., District of Columbia, 20057
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Winston-Salem, North Carolina, 27103
Japan10 sites
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Aichi, 474-8511
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Ehime, 791-0295
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Fukuoka, 816-0864
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Hiroshima, 720-0825
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Hyōgo, 514-8507
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Kanagawa, 247-8533
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Kyoto, 607-8062
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Osaka, 545-8586
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Shizuoka, 424-0911
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Tokyo, 187-8551
Australia9 sites
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Box Hill, Victoria, 3128
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Chermside, Queensland, 4032
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Glen Iris, Victoria, 3146
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Gosford, New South Wales, 2250
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Heidelberg Heights, Victoria, 3081
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Kogarah, New South Wales, 2217
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Melbourne, Victoria, 3004
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Subiaco, Western Australia, 6008
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Toowoomba, Queensland, 4650
Canada7 sites
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Greenfield Park, Quebec, J4V 2J2
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Kelowna, British Columbia, V1Y3G5
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Medicine Hat, Alberta, T1B4E7
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Ottawa, Ontario, K1N 5C8
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Penticton, British Columbia, V2A 5C8
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Sherbrooke, Quebec, J1H1Z1
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Toronto, Ontario, M6M 3Z5
Italy7 sites
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Baggiovara, 41100
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Biella, 13900
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Chieti, 66013
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Genova, 16128
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Lido di Camaiore, 55043
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Milan, 20132
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Rome, 00186
Argentina6 sites
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Buenos Aires, CBA 1419
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Ciudad Automona de Buenos Aire, C1111AAL
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Córdoba, X5004AOA
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Mendoza, 5500
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Rosario, S2000BZL
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Santa Fe, S3000FWO
Germany6 sites
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Berlin, 12203
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Hamburg, 22307
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Hanover, 30559
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Mannheim, 68165
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Munich, D-81675
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Regensburg, 93042
Poland6 sites
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Bydgoszcz, 85-796
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Gliwice, 44-100
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Katowice, 40-588
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Krakow, 31-530
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Lublin, 20-954
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Warsaw, 01-211
Brazil5 sites
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Curitiba, 80060-900
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Itapira, 13970-905
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Porto Alegre, 90110-270
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Rio de Janeiro, 22271-100
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São Paulo, 04024-002
Spain5 sites
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Barcelona, 08014
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Getafe, 28905
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Madrid, 28006
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Plasencia, 10600
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Terrassa, 08221
Sweden5 sites
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Jönköping, 551 85
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Kalmar, 39185
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Lund, 22241
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Mölndal, 43135
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Umeå, 901 85
France4 sites
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Paris, 75475
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Rennes, 35000
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Strasbourg, 67091
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Toulouse, 31300
South Korea4 sites
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Incheon, 400-711
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Seongnam-si, 463-707
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Seoul, 143-729
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Suwon, 443-721
United Kingdom4 sites
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Camberwell, London, SE5 8AF
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London, Greater London, N195NX
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Scotland, Glasgow, G20 0XA
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Uckfield, E Susx, TN225AW
Taiwan3 sites
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Guishan, 33305
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Niaosong, 833
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Taipei, 112
Russia2 sites
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Chelyabinsk, 454091
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Saint Petersburg, 190021
About this study
Official title: Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
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).
- Conditions
- Alzheimer's Disease
- Being tested
- Solanezumab, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolanezumabDrug
Also called LY2062430
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
PlaceboDrug
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
| Study group | Role | What they receive |
|---|---|---|
| Solanezumab | Experimental | Not described Receives: Drug: Solanezumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through Week 104
Secondary outcomes (12)
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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 was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
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 was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels
Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 52
Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
Measured: Baseline, Week 104
Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease
Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. 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 and to subject-specific white matter.
Measured: Baseline, Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2014
- Study completionFeb 2017
Why it stopped: Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127633
- Sponsor's protocol ID
- 11935
- Other IDs
- H8A-MC-LZAO
- Acronym
- EXPEDITION EXT
- Status last verified
- Sep 2019
- First submitted
- 19 May 2010
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01127633
- Acronym / sponsor ID
- EXPEDITION EXT / 11935
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.
- Enrolment
- 1,457 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solanezumab | Experimental | Drug: Solanezumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolanezumabAlso: LY2062430400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years. | Drug | Solanezumab |
| PlaceboParticipants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80. | Drug | Placebo |
Primary outcome
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Time frame: Baseline through Week 104
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
12 secondary outcomes
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
Time frame: Baseline, Week 104
Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels
Time frame: Baseline, Week 52
Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
Time frame: Baseline, Week 104
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
Time frame: Baseline, Week 104
Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease
Time frame: Baseline, Week 104
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
147 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 147 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 147 sites in United States, Japan, Australia, Canada, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) (time frame: Baseline through Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.