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Monoclonal Antibodies

Donanemab for Early Alzheimer's Disease

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of follow-up (91 weeks)
Awards & highlights

Study Summary

This trial will explore how different doses of a drug can help reduce symptoms of Alzheimer's and what factors affect the risk of side effects.

Who is the study for?
This trial is for adults with early symptomatic Alzheimer's who have had memory issues for over 6 months, confirmed amyloid pathology in the brain, and a certain score on a mental state exam. People with serious illnesses, cancer within the last 5 years, life expectancy under 2 years, or significant neurological diseases other than Alzheimer's can't join.Check my eligibility
What is being tested?
The study tests different doses of Donanemab to see how they affect brain swelling (ARIA-E) in people with early Alzheimer's. It also looks at whether certain characteristics predict ARIA risk. Participants will either receive Donanemab or a placebo.See study design
What are the potential side effects?
Donanemab may cause side effects like brain swelling (ARIA-E), which includes symptoms such as headaches, confusion, dizziness, vision changes, and nausea. The severity of these side effects varies among individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of follow-up (91 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of follow-up (91 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Secondary outcome measures
Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies
Percentage of Participants with ARIA-H
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Donanemab Dose Level 4Experimental Treatment2 Interventions
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Group II: Donanemab Dose Level 3Experimental Treatment2 Interventions
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Group III: Donanemab Dose Level 2Experimental Treatment2 Interventions
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Group IV: Donanemab Dose Level 1Experimental Treatment2 Interventions
Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donanemab
2017
Completed Phase 3
~500
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,619 Previous Clinical Trials
3,205,799 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
404,945 Total Patients Enrolled

Media Library

Donanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05738486 — Phase 3
Neurocognitive Disorder Research Study Groups: Donanemab Dose Level 3, Donanemab Dose Level 4, Donanemab Dose Level 1, Donanemab Dose Level 2
Neurocognitive Disorder Clinical Trial 2023: Donanemab Highlights & Side Effects. Trial Name: NCT05738486 — Phase 3
Donanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738486 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being considered for participation in this experimental procedure?

"Those that meet the qualifications of this clinical trial must be aged between 60 and 85. Additionally, there are 426 trials open to those below 18 years old, as well as 1,702 studies for individuals over 65."

Answered by AI

Are there multiple venues in the state where this medical experiment is happening?

"Patients can enroll in this clinical trial at various sites, such as Irvine Clinical Research, Healthy Brain Clinic and California Neuroscience Research LLC. Moreover, there are an additional 34 locations where patients can participate."

Answered by AI

Are there still opportunities for individuals to be involved in this experiment?

"Data posted on clinicaltrials.gov indicates that this medical study is not currently accepting volunteers for participation. The trial was first announced on February 28th 2023 and has since been revised, however no new applicants are being sought at presentment. Fortunately, there are still 2176 other trials in need of patients' assistance."

Answered by AI

Is it permissible to use Donanemab Dose Level 1 based on current FDA regulations?

"Based on the evidence from this Phase 3 trial, Donanemab Dose Level 1 is assessed to be of a safety level 3. This rating reflects both its efficacy and its robustness in demonstrating safety through multiple rounds of testing."

Answered by AI

Is there any possibility that I could join this clinical research?

"This medical trial seeks 800 seniors aged 60 to 85 years old with a confirmed diagnosis of dementia. To qualify, participants must demonstrate at least 6 months of progressive memory loss, score between 20 and 28 on the MMSE test, and have a central read amyloid PET scan result consistent with present amyloid pathology."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center at Houston
Butler Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
2023. "A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05738486.
All > Mental Illness > Mild Cognitive Impairment
~384 spots leftby Apr 2025
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