Clinical trial NCT05463731: A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
Official title: Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Mild cognitive impairment
Alzheimer's disease
Dementia
Amyloid-beta therapy
Amyloid Plaque
Disease modifying
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 1667
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
timeFrame: Week 52
Secondary outcomes:
measure: Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
timeFrame: Week 24
measure: Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
timeFrame: Baseline, Week 24
measure: Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
timeFrame: Up to Week 52
measure: Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
timeFrame: Baseline to Week 52
measure: Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research - Chandler
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Carlsbad
country: United States
facility: North County Neurology Associates
state: California
city: Encino
country: United States
facility: Wr- Pri, Llc
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: La Jolla
country: United States
facility: Kaizen Brain Center
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners, LLc, dba New England Institute for Clinical Research
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Encore Research Group- Jacksonville Center for Clinical Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud - Maitland
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Melbourne
country: United States
facility: ClinCloud - Viera
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: VIN-Andrew Lerman
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology - Airport Boulevard
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Wellington
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center, PC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Andersonville
state: Illinois
city: Elk Grove Village
country: United States
facility: AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
state: Illinois
city: Waterloo
country: United States
facility: Covenant Medical Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center - Central Office
state: Kansas
city: Lake Charles
country: United States
facility: Care Access - Lake Charles
state: Louisiana
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Bolivar
country: United States
facility: Citizens Memorial Hospital District
state: Missouri
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates Albany
state: New York
city: Matthews
country: United States
facility: AMC Research
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Portland
country: United States
facility: Center for Cognitive Health
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, P.C.
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Kerwin Medical Center
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Fairfax
country: United States
facility: Re:Cognition Health
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
city: Toride
country: Japan
facility: Memory Clinic Toride
state: Ibaraki
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Bunkyo-ku
country: Japan
facility: Memory Clinic Ochanomizu
state: Tokyo
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: