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)

FacilityCityStateZIPSite coordinators
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-

Related coverage on Hipa.ai

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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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