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Trial record 2 of 2 for:    AACG

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

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ClinicalTrials.gov Identifier: NCT03367403
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: LY3002813 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3002813
LY3002813 administered intravenously (IV).
Drug: LY3002813
Administered IV

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Change from Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the iADRS score


Secondary Outcome Measures :
  1. Change from Baseline in the Alzheimer's Disease Assessment Scale—Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the ADAS-Cog13 score

  2. Change from Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the CDR-SB score

  3. Change from Baseline in the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the MMSE score

  4. Change from Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the ADCS-iADL score

  5. Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, 18 Months ]
    Change from baseline in brain amyloid plaque deposition as measured by Florbetapir F18 PET scan

  6. Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan [ Time Frame: Baseline, 18 Months ]
    Change from baseline in brain tau deposition as measured by flortaucipir F18 PET scan

  7. Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 18 Months ]
    Change from Baseline in Brain Volume as Measured by vMRI



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
  • MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
  • Meet 18F flortaucipir PET scan criteria.
  • Meet 18F florbetapir PET scan (central read) criteria.

Exclusion Criteria:

  • Have a history of long QT syndrome.
  • Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
  • Contraindication to MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367403


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-839-6631      
Principal Investigator: David Anthony Weidman         
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact    623-832-6530      
Principal Investigator: Edward Zamrini         
United States, California
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
Principal Investigator: Anthony M Ciabarra         
Irvine Clinical Research Center Recruiting
Irvine, California, United States, 92614
Contact    9497531663x226      
Principal Investigator: Elly R Lee         
Institute for Memory Impairment & Neurological Disorders Recruiting
Irvine, California, United States, 92697
Contact    949-824-3250      
Principal Investigator: Joshua Grill         
Pharmacology Research Institute Recruiting
Newport Beach, California, United States, 92660
Contact    949-752-7936      
Principal Investigator: Nader Oskooilar         
Hoag Neuroscience Institue Recruiting
Newport Beach, California, United States, 92663
Contact    949-478-8858      
Principal Investigator: William R Shankle         
Pacific Research Network Inc Recruiting
San Diego, California, United States, 92103
Contact    619-294-4302      
Principal Investigator: Stephen Thein         
Sharp Mesa Vista Hospital Recruiting
San Diego, California, United States, 92123
Contact    858-836-8355      
Principal Investigator: MICHAEL PLOPPER         
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact    7145423008301      
Principal Investigator: John Duffy         
United States, Connecticut
Associated Neurologists, PC - Danbury Recruiting
Danbury, Connecticut, United States, 06810
Contact    203-748-2551      
Principal Investigator: Samuel H Markind         
KI Health Partners, LLC d/b/a NE Inst. for Clin. Res. Recruiting
Stamford, Connecticut, United States, 06905
Contact    203-914-1903      
Principal Investigator: Peter J McAllister         
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Contact    561-968-2933      
Principal Investigator: Mark A Goldstein         
Bradenton Research Center Recruiting
Bradenton, Florida, United States, 34205
Contact    941-708-0005      
Principal Investigator: William McElveen         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact    561-374-8461      
Principal Investigator: Mark Brody         
Infinity Clinical Research, LLC Recruiting
Hollywood, Florida, United States, 33021
Contact    954-366-0277      
Principal Investigator: Harvey Schwartz         
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact    904-730-0101      
Principal Investigator: Carolyn M Tran         
Compass Research Not yet recruiting
Melbourne, Florida, United States, 32940
Contact    321-202-2720      
Principal Investigator: Christopher Galloway         
Merritt Island Medical Research LLC Recruiting
Merritt Island, Florida, United States, 32592
Contact    321-305-5015      
Principal Investigator: Gregory Kirk         
Pharmax Research Clinic Recruiting
Miami, Florida, United States, 33126
Contact    305-262-4321      
Principal Investigator: Jorge M Venereo         
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact    305-514-8535      
Principal Investigator: Marc Agronin         
Suncoast Clinical Research Recruiting
New Port Richey, Florida, United States, 34652
Contact    727-849-4131      
Principal Investigator: Vikram Atit         
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact    407-426-9299      
Principal Investigator: Ira J Goodman         
Palm Beach Neurological Group Recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact    561-694-1010      
Principal Investigator: Michael Tuchman         
Quantum Laboratories Recruiting
Pompano Beach, Florida, United States, 33064
Contact    954-786-7331      
Principal Investigator: Jose E De La Gandara         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact    386-304-7070      
Principal Investigator: Alexander J White         
Intercoastal Medical Group Recruiting
Sarasota, Florida, United States, 34239
Contact    941-203-3750      
Principal Investigator: Mauricio Concha         
Axiom Research Recruiting
Tampa, Florida, United States, 33609
Contact    813-353-9613      
Principal Investigator: SUSAN STEEN         
Stedman Clinical Trials Recruiting
Tampa, Florida, United States, 33613
Contact    813-971-8311      
Principal Investigator: Mary Stedman         
Compass Research Recruiting
The Villages, Florida, United States, 32162
Contact    352-261-0901      
Principal Investigator: Jay J Rubin         
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact    773-275-3500      
Principal Investigator: Jeffrey S. Ross         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact    847-593-8553      
Principal Investigator: CONCETTA FORCHETTI         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-963-7402      
Principal Investigator: Jared Brosch         
Josephson Wallack Munshower Neurology Recruiting
Indianapolis, Indiana, United States, 46256
Contact    317-537-6060      
Principal Investigator: Kristi George         
United States, Kansas
University of Kansas Hospital Recruiting
Fairway, Kansas, United States, 66160
Contact    913-588-0555      
Principal Investigator: Jeffrey M. Burns         
Cotton O'Neil Clinic Recruiting
Topeka, Kansas, United States, 66606
Contact    785-354-9591      
Principal Investigator: Katherine J Willingham         
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact    617-855-3622      
Principal Investigator: BRENT FORESTER         
ActivMed Practices & Research, Inc Recruiting
Methuen, Massachusetts, United States, 01844
Contact    978-655-7155      
Principal Investigator: Michael J McCartney         
Boston Center for Memory Recruiting
Newton, Massachusetts, United States, 02459
Contact    617-699-6927      
Principal Investigator: Paul R. Solomon         
Donald S Marks Recruiting
Plymouth, Massachusetts, United States, 02360-4843
Contact    508-746-5060      
Principal Investigator: Donald Marks         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63108
Contact    314-286-2523      
Principal Investigator: BARBARA SNIDER         
United States, Nevada
Las Vegas Medical Research Recruiting
Las Vegas, Nevada, United States, 89113
Contact    702-750-0222 EXT 102      
Principal Investigator: Bharat R Mocherla         
United States, New Jersey
Advanced Memory Research Institute of New Jersey Recruiting
Toms River, New Jersey, United States, 08755
Contact    732-341-9500      
Principal Investigator: Sanjiv K Sharma         
United States, North Carolina
Behavioral Health Center Research Recruiting
Charlotte, North Carolina, United States, 28211
Contact    704-446-7504      
Principal Investigator: Oleg Tcheremissine         
Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27405
Contact    336-273-2511      
Principal Investigator: Pramod Sethi         
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
Contact    919-782-3456      
Principal Investigator: Bradley J Robottom         
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact    336-794-8165      
Principal Investigator: Franklin Giles Crowell         
United States, Ohio
Insight Clinical Trials Recruiting
Beachwood, Ohio, United States, 44122
Contact    216-526-1843      
Principal Investigator: Deborah Gould         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43220
Contact    614-293-4969      
Principal Investigator: Douglas W. Scharre         
Neurology Diagnostics, Inc. Recruiting
Dayton, Ohio, United States, 45459
Contact    937-224-8200      
Principal Investigator: Joel Vandersluis         
United States, Pennsylvania
Abington Neurological Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact    215-957-9250      
Principal Investigator: David C Weisman         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact    401-444-6440      
Principal Investigator: Brian R. Ott         
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-455-6403      
Principal Investigator: Stephen P Salloway         
United States, Texas
Texas Neurology, PA Recruiting
Dallas, Texas, United States, 75214
Contact    2148273610258      
Principal Investigator: Charles F Greenfield         
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact    713-441-1150      
Principal Investigator: Joseph C Masdeu         
United States, Vermont
The Memory Clinic Completed
Bennington, Vermont, United States, 05201
United States, Virginia
Cognition Health Recruiting
Fairfax, Virginia, United States, 22031
Contact    703-520-9703      
Principal Investigator: James L Bicksel         
National Clinical Research - Richmond Recruiting
Richmond, Virginia, United States, 23294
Contact    804-672-2995      
Principal Investigator: John K Scott         
Canada, Ontario
Bruyere Continuing Care Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact    6135626328      
Principal Investigator: Andrew Frank         
Kawartha Regional Memory Clinic Recruiting
Peterborough, Ontario, Canada, K9H2P4
Contact    7057493906      
Principal Investigator: Donald V Doell         
Toronto Memory Program Recruiting
Toronto, Ontario, Canada, M3B2S7
Contact    4163869761      
Principal Investigator: Sharon Cohen         
Canada, Quebec
Clinique de la Memoire de l'Outaouais Recruiting
Gatineau, Quebec, Canada, J8T 8J1
Contact    8195101000      
Principal Investigator: Richard Bergeron         
DIEX Recherche Sherbrooke, Inc Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Contact    8193462887      
Principal Investigator: Marcel Germain         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03367403     History of Changes
Other Study ID Numbers: 16933
I5T-MC-AACG ( Other Identifier: Eli Lilly and Company )
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
TRAILBLAZER-ALZ

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders