A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Alzheimer's Disease Clinical Trial

Official title:

Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463731
• Other study ID #: 18467
• Secondary ID: J1G-MC-LAKC
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).

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 enrollin 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 52 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 640 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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Gradual and progressive change in cognitive function =6 months prior to screening.

• A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.

• Has a P-tau result consistent with the presence of amyloid pathology.

• Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.

• 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:

• Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.

• 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 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 that is <5 half-lives prior to randomization.

• Have received active immunization against Aß in any other study.

• Have known allergies to remternetug related compounds, or any components of the formulation.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Remternetug (IV)
Administered IV
• Remternetug (SC)
Administered SC
• Placebo
Administered IV or SC

Locations

Country	Name	City	State
Japan	Memory Clinic Ochanomizu	Bunkyo-ku	Tokyo
Japan	Katayama Medical Clinic	Kurashiki	Okayama
Japan	Memory Clinic Toride	Toride	Ibaraki
United States	Neurological Associates Albany	Albany	New York
United States	JEM Research Institute	Atlantis	Florida
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	VIN-Julie Schwartzbard	Aventura	Florida
United States	Mountain Neurological Research Center	Basalt	Colorado
United States	Gadolin Research	Beaumont	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Citizens Memorial Hospital District	Bolivar	Missouri
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	NeuroScience Research Center	Canton	Ohio
United States	North County Neurology Associates	Carlsbad	California
United States	Valley Medical Research	Centerville	Ohio
United States	MD First Research - Chandler	Chandler	Arizona
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Columbus Memory Center, PC	Columbus	Georgia
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	Kerwin Medical Center	Dallas	Texas
United States	Neurology Consultants of Dallas, PA	Dallas	Texas
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research	Elk Grove Village	Illinois
United States	Wr- Pri, Llc	Encino	California
United States	Re:Cognition Health	Fairfax	Virginia
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Neuro-Pain Medical Center	Fresno	California
United States	Finlay Medical Research	Greenacres City	Florida
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Irvine Clinical Research	Irvine	California
United States	Encore Research Group- Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Kaizen Brain Center	La Jolla	California
United States	Care Access - Lake Charles	Lake Charles	Louisiana
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	ClinCloud - Maitland	Maitland	Florida
United States	K2 Medical Research	Maitland	Florida
United States	AMC Research	Matthews	North Carolina
United States	ClinCloud - Viera	Melbourne	Florida
United States	Merritt Island Medical Research, LLC	Merritt Island	Florida
United States	Optimus U Corporation	Miami	Florida
United States	VIN-Andrew Lerman	Miami	Florida
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Charter Research - Winter Park	Orlando	Florida
United States	Emerald Coast Neurology - Airport Boulevard	Pensacola	Florida
United States	Keystone Clinical Studies	Plymouth Meeting	Pennsylvania
United States	Progressive Medical Research	Port Orange	Florida
United States	Center for Cognitive Health	Portland	Oregon
United States	Anderson Clinical Research	Redlands	California
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Central Texas Neurology Consultants	Round Rock	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	Ki Health Partners, LLc, dba New England Institute for Clinical Research	Stamford	Connecticut
United States	Alzheimer's Research and Treatment Center	Stuart	Florida
United States	Brain Matters Research	Stuart	Florida
United States	Universal Research Group	Tacoma	Washington
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	Charter Research - Lady Lake	The Villages	Florida
United States	Advanced Memory Research Institute of New Jersey	Toms River	New Jersey
United States	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Covenant Medical Center	Waterloo	Iowa
United States	Adams Clinical	Watertown	Massachusetts
United States	Alzheimer's Research and Treatment Center	Wellington	Florida
United States	Palm Beach Neurology	West Palm Beach	Florida
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo		Week 52
Secondary	Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo		Baseline, Week 52
Secondary	Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo		Week 24
Secondary	Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo		Baseline, Week 24
Secondary	Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo		Up to Week 52
Secondary	Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug		Baseline to Week 52
Secondary	Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)		Baseline to Week 52

External Links

•   A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)