A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05738486
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Alzheimer's Disease
  • Brain Diseases
  • Central Nervous System Diseases
  • Dementia
  • Mental Disorders
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Neurodegenerative Diseases

Eligibility Criteria

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

Interventions

  • Donanemab — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV
  • Dexamethasone — DRUG
    Administered IV

Study Details

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled per addendum. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Key Dates

Start date
Feb 28, 2023
Status verified
Oct 2025
Primary completion
May 16, 2024
Completion
May 31, 2027

Study Design

Enrollment
1,175 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1400 mg Donanemab - Standard Regimen
    Participants received: * 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. * placebo administered IV at week 2, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
  • Experimental: 1400 mg Donanemab - Dose Skipping
    Participants received: * 700 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 4, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
  • Experimental: 1400 mg Donanemab - Titration
    Participants received: * 350 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 6, 10, and 14. * 700 mg donanemab administered IV at week 4. * 1050 mg of donanemab administered IV at week 8. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
  • Experimental: 1400 mg Donanemab - Maximum Concentration (Cmax)
    Participants received: * 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. * 700 mg donanemab administered IV at weeks 12 and 14. * 1400 mg of donanemab administered IV at weeks 16, 20, and 24.
  • Experimental: Donanemab Addendum Arm 1
    Participants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion.
  • Experimental: Donanemab Addendum Arm 2
    Participants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion

Primary Outcome Measure

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) [ Time Frame: 24 Weeks ]

Locations (43)

FacilityCityStateZIP
MD First Research - ChandlerChandlerArizona85286
Irvine Clinical ResearchIrvineCalifornia92614
Healthy Brain ClinicLong BeachCalifornia90804
California Neuroscience Research Medical Group, Inc.Sherman OaksCalifornia91403
JEM Research InstituteAtlantisFlorida33462
VIN-Julie SchwartzbardAventuraFlorida33180
Excel Medical Clinical TrialsBoca RatonFlorida33434
K2 Medical ResearchClermontFlorida34711
Brain Matters ResearchDelray BeachFlorida33445
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912
Finlay Medical ResearchGreenacres CityFlorida33467
Infinity Clinical Research, LLCHollywoodFlorida33024
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216
ClinCloud - MaitlandMaitlandFlorida32751
K2 Medical ResearchMaitlandFlorida32751
ClinCloud - VieraMelbourneFlorida32940
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652
Renstar Medical ResearchOcalaFlorida34470
Charter Research - Winter ParkOrlandoFlorida32803
Progressive Medical ResearchPort OrangeFlorida32127
Alzheimer's Research and Treatment CenterStuartFlorida34997
K2 Medical Research - TampaTampaFlorida33607
Charter Research - Lady LakeThe VillagesFlorida32162
K2 Summit ResearchThe VillagesFlorida32159
Alzheimer's Research and Treatment CenterWellingtonFlorida33414
Palm Beach NeurologyWest Palm BeachFlorida33407
Conquest ResearchWinter ParkFlorida32789
Columbus Memory Center, LLCColumbusGeorgia31909
CenExel iResearch, LLCDecaturGeorgia30030
Center for Advanced Research & EducationGainesvilleGeorgia30501
CenExel iResearch, LLCSavannahGeorgia31405
MedVadis Research CorporationWalthamMassachusetts02451
Adams ClinicalWatertownMassachusetts02472
QUEST Research InstituteFarmington HillsMichigan48334
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081
Butler HospitalProvidenceRhode Island02906
Neurology Clinic, P.C.CordovaTennessee38018
Gadolin ResearchBeaumontTexas77702
Kerwin Medical CenterDallasTexas75231
The University of Texas Health Science Center at HoustonHoustonTexas77054
Re:Cognition HealthFairfaxVirginia22031
Northwest Clinical Research CenterBellevueWashington98007
Universal Research GroupTacomaWashington98405

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MD First Research - Chandler· Chandler, AZIrvine Clinical Research· Irvine, CAHealthy Brain Clinic· Long Beach, CACalifornia Neuroscience Research Medical Group, Inc.· Sherman Oaks, CAJEM Research Institute· Atlantis, FLVIN-Julie Schwartzbard· Aventura, FL

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