A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Remternetug (IV)Drug: Remternetug (SC)Drug: Placebo
- Registration Number
- NCT05463731
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).
- Detailed Description
TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Initially, 600 participants will enroll in the double-blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.
Following the 52-week main study period, participants will continue participation for up to an additional 76 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.
An additional 974 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1667
- Gradual and progressive change in cognitive function ≥6 months prior to screening.
- A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.
- Has an amyloid PET scan result consistent with the eligibility criteria.
- Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
- Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Males and females will be eligible for this study.
- Women not of childbearing potential (WNOCBP) may participate in this trial.
- Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
- History of cancer with high risk of recurrence and preventing completion of the trial.
- Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
- History of clinically significant multiple or severe drug allergies.
- Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
- Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
- Have any contraindications for MRI or positron emission tomography (PET).
- Have had prior treatment with a passive anti-amyloid immunotherapy.
- Have received active immunization against Aβ in any other study.
- Have known allergies to remternetug related compounds, or any components of the formulation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remternetug (IV) Remternetug (IV) Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period. Remternetug (SC) Remternetug (SC) Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period. Placebo Placebo Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period. Open-Label Addenda Remternetug (IV) Remternetug (IV) Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda. Open-Label Addenda Remternetug (SC) Remternetug (SC) Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Week 52
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Week 24 Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo Baseline, Week 24 Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug Baseline to Week 52 Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) Baseline to Week 52 Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo Up to Week 52
Trial Locations
- Locations (74)
ClinCloud - Viera
🇺🇸Melbourne, Florida, United States
Central Texas Neurology Consultants
🇺🇸Round Rock, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Wr- Pri, Llc
🇺🇸Encino, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
North County Neurology Associates
🇺🇸Carlsbad, California, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Kaizen Brain Center
🇺🇸La Jolla, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Mountain Neurological Research Center
🇺🇸Basalt, Colorado, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Brain Matters Research
🇺🇸Stuart, Florida, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Encore Research Group- Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
ClinCloud - Maitland
🇺🇸Maitland, Florida, United States
VIN-Andrew Lerman
🇺🇸Miami, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
Merritt Island Medical Research, LLC
🇺🇸Merritt Island, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Emerald Coast Neurology - Airport Boulevard
🇺🇸Pensacola, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Alzheimer's Research and Treatment Center
🇺🇸Wellington, Florida, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Columbus Memory Center, PC
🇺🇸Columbus, Georgia, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
🇺🇸Elk Grove Village, Illinois, United States
Great Lakes Clinical Trials - Andersonville
🇺🇸Chicago, Illinois, United States
Covenant Medical Center
🇺🇸Waterloo, Iowa, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Citizens Memorial Hospital District
🇺🇸Bolivar, Missouri, United States
Advanced Memory Research Institute of New Jersey
🇺🇸Toms River, New Jersey, United States
Neurological Associates Albany
🇺🇸Albany, New York, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
AMC Research
🇺🇸Matthews, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
NeuroScience Research Center
🇺🇸Canton, Ohio, United States
Neurology Diagnostics, Inc.
🇺🇸Dayton, Ohio, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Keystone Clinical Studies
🇺🇸Plymouth Meeting, Pennsylvania, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Kerwin Medical Center
🇺🇸Dallas, Texas, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Neurology Consultants of Dallas, PA
🇺🇸Dallas, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Re:Cognition Health
🇺🇸Fairfax, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Universal Research Group
🇺🇸Tacoma, Washington, United States
Memory Clinic Toride
🇯🇵Toride, Ibaraki, Japan
Memory Clinic Ochanomizu
🇯🇵Bunkyo-ku, Tokyo, Japan
Cotton O'Neil Clinical Research Center - Central Office
🇺🇸Topeka, Kansas, United States
Katayama Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Care Access - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
Center for Cognitive Health
🇺🇸Portland, Oregon, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States