A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT07589595
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Amyloid
  • Cognitive Dysfunction
  • Lewy Body Disease
  • Synucleinopathies

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Donanemab — DRUG
    Donanemab administered IV
  • Placebo — DRUG
    Placebo administered IV

Study Details

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab (LY3002813)
    Donanemab (LY3002813) administered as an intravenous (IV) infusion
  • Placebo Comparator: Placebo
    Placebo administered IV

Primary Outcome Measure

Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline through Week 52 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (42)

FacilityCityStateZIPSite coordinators
TrialSphere CorpChandlerArizona85286
480-508-1038
Hemant Pandey (PRINCIPAL_INVESTIGATOR)
HonorHealth Research InstituteScottsdaleArizona85258
Todd Levine (PRINCIPAL_INVESTIGATOR)
Profound Research LLCCarlsbadCalifornia92011
760-631-3000
Benjamin Frishberg (PRINCIPAL_INVESTIGATOR)
Irvine Clinical ResearchIrvineCalifornia92614
949-753-1663
Edward Zamrini (PRINCIPAL_INVESTIGATOR)
UCSD - Altman Clinical and Translational Research Institute (ACTRI)La JollaCalifornia92037
Stephanie Lessig (PRINCIPAL_INVESTIGATOR)
Stanford Neuroscience Health CenterPalo AltoCalifornia94304
818-398-9855
Irina Skylar-Scott (PRINCIPAL_INVESTIGATOR)
CenExel Rocky Mountain Clinical ResearchEnglewoodColorado80113
Meagen Salinas (PRINCIPAL_INVESTIGATOR)
Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamfordConnecticut06905
203-914-1903
Peter McAllister (PRINCIPAL_INVESTIGATOR)
JEM Research InstituteAtlantisFlorida33462
561-968-2933
Linda Pao (PRINCIPAL_INVESTIGATOR)
VIN - AventuraAventuraFlorida33180
305-933-5993
Jonathan Cross (PRINCIPAL_INVESTIGATOR)
Brain Matters ResearchDelray BeachFlorida33445
561-374-8461
Paayal Patel (PRINCIPAL_INVESTIGATOR)
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912
239-939-7777
John Huffaker (PRINCIPAL_INVESTIGATOR)
Norman Fixel Institute for Neurological Diseases (FIND)GainesvilleFlorida32608
Bhavana Patel (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Neill Graff-Radford (PRINCIPAL_INVESTIGATOR)
K2 Medical Research ORLANDOMaitlandFlorida32751
407-500-5252
Sheila Baez-Torres (PRINCIPAL_INVESTIGATOR)
BRP-Kendal LakesMiamiFlorida33175
Jose Gonzalez (PRINCIPAL_INVESTIGATOR)
Renstar Medical ResearchOcalaFlorida34471
352-629-5800
Anette Nieves (PRINCIPAL_INVESTIGATOR)
Charter Research - OrlandoOrlandoFlorida32803
407-337-1000
Diana Balsalobre (PRINCIPAL_INVESTIGATOR)
Axiom Brain Health LLCTampaFlorida33609
813-353-9613
Susan Steen (PRINCIPAL_INVESTIGATOR)
Palm Beach NeurologyWest Palm BeachFlorida33407
561-845-0500
Paul Winner (PRINCIPAL_INVESTIGATOR)
Conquest ResearchWinter ParkFlorida32789
407-916-0060
Malisa Agard (PRINCIPAL_INVESTIGATOR)
Indiana University Health Neuroscience CenterIndianapolisIndiana46202
317-963-7402
Jared Brosch (PRINCIPAL_INVESTIGATOR)
The University of Kansas - Clinical Research CenterFairwayKansas66205
913-574-0976
Ryan Townley (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital - CharlestownCharlestownMassachusetts02129
Anna Goodheart (PRINCIPAL_INVESTIGATOR)
Neurology Center of New EnglandFoxboroughMassachusetts02035
781-551-5812
Salvatore Napoli (PRINCIPAL_INVESTIGATOR)
Headlands Eastern MA LLCPlymouthMassachusetts02360
978-831-8041
Kinan Hreib (PRINCIPAL_INVESTIGATOR)
QUEST Research InstituteFarmington HillsMichigan48334
248-957-8940
Aaron Ellenbogen (PRINCIPAL_INVESTIGATOR)
Struthers Parkinson's CenterGolden ValleyMinnesota55427
Sotirios Parashos (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
Jonathan Graff-Radford (PRINCIPAL_INVESTIGATOR)
Citizens Memorial Hospital DistrictBolivarMissouri65613
417-328-7781
Curtis Schreiber (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Aimee Pierce (PRINCIPAL_INVESTIGATOR)
Summit HeadlandsPortlandOregon97210
503-279-8252
Scott Losk (PRINCIPAL_INVESTIGATOR)
Pennsylvania HospitalPhiladelphiaPennsylvania19107
Rebecca Williamson (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - East ProvidenceEast ProvidenceRhode Island02914
401-435-8950
john stoukides (PRINCIPAL_INVESTIGATOR)
Gadolin ResearchBeaumontTexas77702
409-331-6040
Kandasami Senthilkumar (PRINCIPAL_INVESTIGATOR)
Kerwin Medical CenterDallasTexas75231
Alka Khera (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Juan Toledo Atucha (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77054
713-486-0536
David Hunter (PRINCIPAL_INVESTIGATOR)
Central Texas Neurology ConsultantsRound RockTexas78681
512-218-1222
Elizabeth Peckham (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science CenterSan AntonioTexas78229
Sudha Seshadri (PRINCIPAL_INVESTIGATOR)
Re:Cognition HealthFairfaxVirginia22031
703-520-9703
Raymond Turner (PRINCIPAL_INVESTIGATOR)
EvergreenHealthKirklandWashington98034
425-899-5385
Pinky Agarwal (PRINCIPAL_INVESTIGATOR)

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