Clinical trial NCT00904683: Effect of LY2062430 on the Progression of Alzheimer's Disease
Official title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 1040
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
timeFrame: Baseline, Week 80
Secondary outcomes:
measure: Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Plasma Amyloid Beta Levels
timeFrame: Baseline, Week 80
measure: 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)
timeFrame: Baseline, Week 80
measure: Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score
timeFrame: Baseline, Week 80
Other outcomes:
Locations:
city: Tucson
country: United States
facility: 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.
state: Arizona
city: Los Angeles
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Francisco
country: United States
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state: California
city: Santa Monica
country: United States
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state: California
city: New Haven
country: United States
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state: Connecticut
city: Miami
country: United States
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state: Florida
city: Tampa Bay
country: United States
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state: Florida
city: Hattiesburg
country: United States
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state: Mississippi
city: Creve Coeur
country: United States
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state: Missouri
city: Kansas City
country: United States
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state: Missouri
city: Amherst
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Portland
country: United States
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state: Oregon
city: San Antonio
country: United States
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state: Texas
city: Seattle
country: United States
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state: Washington
city: Bankstown
country: Australia
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state: New South Wales
city: Darlinghurst
country: Australia
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state: New South Wales
city: Gosford
country: Australia
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state: New South Wales
city: Kogarah
country: Australia
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state: New South Wales
city: Chermside
country: Australia
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state: Queensland
city: Toowoomba
country: Australia
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state: Queensland
city: Box Hill
country: Australia
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state: Victoria
city: Glen Iris
country: Australia
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state: Victoria
city: Heidelberg Heights
country: Australia
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state: Victoria
city: Melbourne
country: Australia
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state: Victoria
city: Subiaco
country: Australia
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state: Western Australia
city: Aix En Provence
country: France
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city: Paris
country: France
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city: Rennes
country: France
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city: Strasbourg
country: France
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city: Toulouse
country: France
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city: Berlin
country: Germany
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city: Hamburg
country: Germany
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city: Hannover
country: Germany
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city: Mannheim
country: Germany
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city: Marburg
country: Germany
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city: Munchen
country: Germany
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city: München
country: Germany
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city: Regensburg
country: Germany
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city: Biella
country: Italy
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city: Boggiovara
country: Italy
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city: Cassino
country: Italy
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city: Chieti
country: Italy
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city: Genova
country: Italy
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city: Lido Di Camaiore
country: Italy
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city: Milano
country: Italy
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city: Rome
country: Italy
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city: Ehime
country: Japan
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city: Fukuoka
country: Japan
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city: Hyogo
country: Japan
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city: Kanagawa
country: Japan
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city: Kyoto
country: Japan
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city: Osaka
country: Japan
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city: Shizuoka
country: Japan
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city: Tokyo
country: Japan
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city: Incheon
country: Korea, Republic of
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city: Seongnam-Si
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Suwon
country: Korea, Republic of
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city: Bialystok
country: Poland
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city: Bydgoszcz
country: Poland
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city: Gliwice
country: Poland
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city: Katowice
country: Poland
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city: Krakow
country: Poland
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city: Lublin
country: Poland
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city: Warsaw
country: Poland
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city: Chelyabinsk
country: Russian Federation
facility: 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.
city: Ekaterinburg
country: Russian Federation
facility: 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.
city: Rostov-On-Don
country: Russian Federation
facility: 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.
city: Saint Petersburg
country: Russian Federation
facility: 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.
city: Barcelona
country: Spain
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city: Getafe
country: Spain
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city: Madrid
country: Spain
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city: Plasencia
country: Spain
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city: Terrassa
country: Spain
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city: Joenkoeping
country: Sweden
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city: Kalmar
country: Sweden
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city: Lund
country: Sweden
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city: Malmo
country: Sweden
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city: Molndal
country: Sweden
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city: Stockholm
country: Sweden
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city: Umea
country: Sweden
facility: 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.
city: Kaohsiung
country: Taiwan
facility: 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.
city: Niao Sung Hsiang
country: Taiwan
facility: 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.
city: Taichung
country: Taiwan
facility: 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.
city: Taipei
country: Taiwan
facility: 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.
city: Tao-Yuan
country: Taiwan
facility: 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.
city: Yung-Kang, Tainan
country: Taiwan
facility: 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.
city: Uckfield
country: United Kingdom
facility: 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.
state: E Susx
city: Scotland
country: United Kingdom
facility: 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.
state: Glasgow
city: London
country: United Kingdom
facility: 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.
state: Greater London
city: Camberwell
country: United Kingdom
facility: 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.
state: London
city: Sheffield
country: United Kingdom
facility: 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.
state: Syorks
city: Swindon
country: United Kingdom
facility: 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.
state: Wiltshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.