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

Dementia Clinical Trial

Official title:

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738486
• Other study ID #: 18648
• Secondary ID: I5T-MC-AACQ2022-
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Gradual and progressive change in memory function reported by the participant or informant for =6 months.

• A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.

• Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion Criteria:

• Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.

• Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.

• A life expectancy of <24 months

• Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

• non-metastatic basal- or squamous-cell skin cancer

• Stage 0 non-invasive carcinoma of the cervix

• Stage 0 non-invasive prostate cancer, or

• other cancers with low risk of recurrence or spread

• Contraindication to MRI or PET scans

• Have had prior treatment with a passive anti-amyloid immunotherapy.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Donanemab
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
United Kingdom	Re:Cognition Health - Birmingham	Birmingham
United Kingdom	Re:Cognition Health - Bristol	Bristol	Bristol, City Of
United Kingdom	Re:Cognition Health Guildford	Guildford	Reading
United Kingdom	Re:Cognition Health - London	London	London, City Of
United Kingdom	Re:Cognition Health - Plymouth	Plymouth
United Kingdom	Re:Cognition Health - Winchester	Winchester	Hampshire
United States	JEM Research Institute	Atlantis	Florida
United States	VIN-Julie Schwartzbard	Aventura	Florida
United States	Gadolin Research	Beaumont	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	MD First Research - Chandler	Chandler	Arizona
United States	K2 Medical Research	Clermont	Florida
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	iResearch Atlanta	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Re:Cognition Health	Fairfax	Virginia
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Finlay Medical Research	Greenacres City	Florida
United States	Infinity Clinical Research, LLC	Hollywood	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	Healthy Brain Clinic	Long Beach	California
United States	ClinCloud - Maitland	Maitland	Florida
United States	K2 Medical Research	Maitland	Florida
United States	ClinCloud - Viera	Melbourne	Florida
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	Progressive Medical Research	Port Orange	Florida
United States	Butler Hospital	Providence	Rhode Island
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	Alzheimer's Research and Treatment Center	Stuart	Florida
United States	Universal Research Group	Tacoma	Washington
United States	K2 Medical Research - Tampa	Tampa	Florida
United States	Charter Research - Lady Lake	The Villages	Florida
United States	K2 Summit Research	The Villages	Florida
United States	MedVadis Research Corporation	Waltham	Massachusetts
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,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)		24 Weeks
Secondary	Percentage of Participants with Any Occurence of ARIA-E		52 Weeks
Secondary	Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan		Baseline, 76 Weeks
Secondary	Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)		24 Weeks
Secondary	Percentage of Participants with ARIA-H		52 Weeks
Secondary	Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H		52 Weeks
Secondary	Pharmacokinetics (PK): Average Serum Concentration of Donanemab		Baseline to 52 Weeks
Secondary	Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies		Baseline to End of Follow-Up (91 Weeks)

External Links

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