AzTrials
AzTrials

Alzheimer's DiseasePhase 3EXPEDITION2NCT00904683

Effect of LY2062430 on the Progression of Alzheimer's Disease

A Phase 3 study testing LY2062430 in people with Alzheimer's Disease, run by Eli Lilly and Company at 95 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
LY2062430
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,040 participants
Where
95 sitesin 13 countries
Study dates
May 2009to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 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

Who cannot join

  • 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
Show all 9Show fewer
  • Chronic alcohol and/or drug abuse within the past 5 years
  • Has any contraindications for MRI studies
  • Requires treatment with another monoclonal antibody

Trial locations and contacts

95 sites in 13 countries.

95 sites in 13 countries

United States16 sites
  • 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.

    Amherst, New York, 14226

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    Creve Coeur, Missouri, 63141

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    Hattiesburg, Mississippi, 39401

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    Kansas City, Missouri, 64114

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    Los Angeles, California, 90033

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    Miami, Florida, 33137

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    New Haven, Connecticut, 06510

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    Portland, Oregon, 97210

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    San Antonio, Texas, 78229

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    San Diego, California, 92103

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    San Francisco, California, 94109

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    Santa Monica, California, 90404

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    Seattle, Washington, 98108

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    Staten Island, New York, 10312

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    Tampa Bay, Florida, 33613

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    Tucson, Arizona, 85741

Other trials in United States

Australia11 sites
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    Bankstown, New South Wales, 2200

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    Box Hill, Victoria, 3128

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    Chermside, Queensland, 4032

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    Darlinghurst, New South Wales, 2010

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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

Other trials in Australia

Germany8 sites
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    Berlin, D-12200

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    Hamburg, 22307

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    Hanover, 30559

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    Mannheim, 68165

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    Marburg, 35033

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    München, BY 80336

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    München, D-81675

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    Regensburg, 93042

Other trials in Germany

Italy8 sites
  • 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.

    Biella, 13900

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    Boggiovara, 41100

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    Cassino, 03043

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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, 00179

Other trials in Italy

Japan8 sites
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    Ehime, 791-0295

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    Fukuoka, 816-0864

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    Hyōgo, 514-8507

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    Kanagawa, 247-0072

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    Kyoto, 606-0851

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    Osaka, 558-0056

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    Shizuoka, 424-0911

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    Tokyo, 173

Other trials in Japan

Poland7 sites
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    Bialystok, 15-617

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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, 20-090

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    Warsaw, 02-777

Other trials in Poland

Sweden7 sites
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    Jönköping, 551 85

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    Kalmar, 39185

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    Lund, 22241

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    Malmö, 20502

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    Mölndal, 43135

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    Stockholm, 14186

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    Umeå, 901 85

Other trials in Sweden

Taiwan6 sites
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    Kaohsiung City, 807

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    Niao Sung Hsiang, 83301

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    Taichung, 404

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    Taipei, 112

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    Taoyuan, 333

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    Yung-Kang, Tainan, 710

Other trials in Taiwan

United Kingdom6 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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    Sheffield, Syorks, S57JT

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    Swindon, Wiltshire, SN3 6BW

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    Uckfield, E Susx, TN225AW

Other trials in United Kingdom

France5 sites
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    Aix-en-Provence, 13100

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    Paris, 75475

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    Rennes, 35000

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    Strasbourg, 67091

  • 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.

    Toulouse, 31300

Other trials in France

Spain5 sites
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    Barcelona, 08014

  • 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.

    Getafe, 28905

  • 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.

    Madrid, 28034

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    Plasencia, 10600

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    Terrassa, 0821

Other trials in Spain

Russia4 sites
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    Chelyabinsk, 454091

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    Rostov-on-Don, 344010

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    Saint Petersburg, 190021

  • 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.

    Yekaterinburg, 620030

Other trials in Russia

South Korea4 sites
  • 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.

    Incheon, 400-711

  • 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.

    Seongnam-si, 463-707

  • 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.

    Seoul, 143-729

  • 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.

    Suwon, 443-721

Other trials in South Korea

About this study

Official title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

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.

Being tested
LY2062430, 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.

  • LY2062430Drug

    Also called A Beta Antibody, Solanezumab (*USAN adopted name, INN pending)

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

  • PlaceboDrug

    intravenously (IV) every 4 weeks for 80 weeks

Study groups in NCT00904683
Study groupRoleWhat they receive
LY2062430ExperimentalNot described
Receives: Drug: LY2062430
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Week 80

Secondary outcomes (10)
  1. Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

    Measured: Baseline, Week 80

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

    Measured: Baseline, Week 80

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

    Measured: Baseline, Week 80

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

    Measured: Baseline, Week 80

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

    Measured: Baseline, Week 80

  6. Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score

    Measured: Baseline, Week 80

  7. Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score

    Measured: Baseline, Week 80

  8. Change from Baseline to Week 80 in Plasma Amyloid Beta Levels

    Measured: Baseline, Week 80

  9. 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)

    Measured: Baseline, Week 80

  10. Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score

    Measured: Baseline, Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,040 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00904683
Sponsor's protocol ID
11934
Other IDs
H8A-MC-LZAN
Acronym
EXPEDITION2
Status last verified
Dec 2012
First submitted
18 May 2009
Last updated
13 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40603145
  • 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.

    PubMed 36946603
  • 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.

    PubMed 29615123
  • 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.

    PubMed 26402769
  • 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.

    PubMed 26120369
  • 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.

    PubMed 25125457
  • 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.

    PubMed 24450890

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY2062430 in people with Alzheimer's Disease, run by Eli Lilly and Company at 95 sites in 13 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 9 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: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Australia, Germany, Italy, Japan and 8 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14) (time frame: Baseline, Week 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904683, which also lists 7 linked publications.

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 13 Dec 2012.

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