NCT00904683

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,040

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2009

Typical duration for phase_3

Geographic Reach
13 countries

95 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

3.1 years

First QC Date

May 18, 2009

Last Update Submit

December 11, 2012

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)

    Baseline, Week 80

Secondary Outcomes (10)

  • Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

    Baseline, Week 80

  • Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score

    Baseline, Week 80

  • Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)

    Baseline, Week 80

  • Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score

    Baseline, Week 80

  • Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score

    Baseline, Week 80

  • +5 more secondary outcomes

Study Arms (2)

LY2062430

EXPERIMENTAL
Drug: LY2062430

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LY2062430DRUG

400 mg intravenously (IV) every 4 weeks for 80 weeks

Also known as: A Beta Antibody, Solanezumab (*USAN adopted name, INN pending)
LY2062430
PlaceboDRUG

intravenously (IV) every 4 weeks for 80 weeks

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (95)

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Tucson, Arizona, 85741, United States

Location

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Los Angeles, California, 90033, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94109, United States

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Santa Monica, California, 90404, United States

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New Haven, Connecticut, 06510, United States

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Miami, Florida, 33137, United States

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Tampa Bay, Florida, 33613, United States

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Hattiesburg, Mississippi, 39401, United States

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Creve Coeur, Missouri, 63141, United States

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Kansas City, Missouri, 64114, United States

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Amherst, New York, 14226, United States

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Staten Island, New York, 10312, United States

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Portland, Oregon, 97210, United States

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San Antonio, Texas, 78229, United States

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Seattle, Washington, 98108, United States

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Bankstown, New South Wales, 2200, Australia

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Darlinghurst, New South Wales, 2010, Australia

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Gosford, New South Wales, 2250, Australia

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Kogarah, New South Wales, 2217, Australia

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Chermside, Queensland, 4032, Australia

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Toowoomba, Queensland, 4650, Australia

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Box Hill, Victoria, 3128, Australia

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Glen Iris, Victoria, 3146, Australia

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Heidelberg Heights, Victoria, 3081, Australia

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Melbourne, Victoria, 3004, Australia

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Subiaco, Western Australia, 6008, Australia

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Aix-en-Provence, 13100, France

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Paris, 75475, France

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Rennes, 35000, France

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Strasbourg, 67091, France

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Toulouse, 31300, France

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Berlin, D-12200, Germany

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Hamburg, 22307, Germany

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Hanover, 30559, Germany

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Mannheim, 68165, Germany

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Marburg, 35033, Germany

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München, BY 80336, Germany

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München, D-81675, Germany

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Regensburg, 93042, Germany

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Biella, 13900, Italy

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Boggiovara, 41100, Italy

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Cassino, 03043, Italy

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Chieti, 66013, Italy

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Genova, 16128, Italy

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Lido di Camaiore, 55043, Italy

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Milan, 20132, Italy

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Rome, 00179, Italy

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Ehime, 791-0295, Japan

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Fukuoka, 816-0864, Japan

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Hyōgo, 514-8507, Japan

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Kanagawa, 247-0072, Japan

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Kyoto, 606-0851, Japan

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Osaka, 558-0056, Japan

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Shizuoka, 424-0911, Japan

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Tokyo, 173, Japan

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Bialystok, 15-617, Poland

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Bydgoszcz, 85-796, Poland

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Gliwice, 44-100, Poland

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Katowice, 40-588, Poland

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Krakow, 31-530, Poland

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Lublin, 20-090, Poland

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Warsaw, 02-777, Poland

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Chelyabinsk, 454091, Russia

Location

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Rostov-on-Don, 344010, Russia

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Saint Petersburg, 190021, Russia

Location

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Yekaterinburg, 620030, Russia

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Incheon, 400-711, South Korea

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Seongnam-si, 463-707, South Korea

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Seoul, 143-729, South Korea

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Suwon, 443-721, South Korea

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Barcelona, 08014, Spain

Location

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Getafe, 28905, Spain

Location

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Madrid, 28034, Spain

Location

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Plasencia, 10600, Spain

Location

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Terrassa, 0821, Spain

Location

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Jönköping, 551 85, Sweden

Location

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Kalmar, 39185, Sweden

Location

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Lund, 22241, Sweden

Location

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Malmo, 20502, Sweden

Location

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Mölndal, 43135, Sweden

Location

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Stockholm, 14186, Sweden

Location

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Umeå, 901 85, Sweden

Location

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Kaohsiung City, 807, Taiwan

Location

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Niao Sung Hsiang, 83301, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taipei, 112, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

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Yung-Kang, Tainan, 710, Taiwan

Location

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Uckfield, E Susx, TN225AW, United Kingdom

Location

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Scotland, Glasgow, G20 0XA, United Kingdom

Location

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London, Greater London, N195NX, United Kingdom

Location

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Camberwell, London, SE5 8AF, United Kingdom

Location

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Sheffield, Syorks, S57JT, United Kingdom

Location

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Swindon, Wiltshire, SN3 6BW, United Kingdom

Location

Related Publications (7)

  • Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.

    PMID: 40603145DERIVED

  • Holdridge KC, Yaari R, Hoban DB, Andersen S, Sims JR. Targeting amyloid beta in Alzheimer's disease: Meta-analysis of low-dose solanezumab in Alzheimer's disease with mild dementia studies. Alzheimers Dement. 2023 Oct;19(10):4619-4628. doi: 10.1002/alz.13031. Epub 2023 Mar 22.

    PMID: 36946603DERIVED

  • 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.

    PMID: 29615123DERIVED

  • 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.

    PMID: 26402769DERIVED

  • 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.

    PMID: 26120369DERIVED

  • 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.

    PMID: 25125457DERIVED

  • 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.

    PMID: 24450890DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

solanezumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

DE(8)RU(4)KR(4)US(16)ES(5)TW(6)GB(6)SE(7)PL(7)FR(5)IT(8)AU(11)JP(8)