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Monoclonal Antibodies

Donanemab for Alzheimer's Disease

Phase 3
Waitlist Available
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 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing two medications, donanemab and aducanumab, to see which is better at removing harmful protein clumps from the brains of people with early Alzheimer's disease. These protein clumps, called amyloid plaques, are thought to contribute to the symptoms of Alzheimer's. The goal is to find out if one medication is more effective than the other in helping patients. Aducanumab is the first FDA-approved drug that targets amyloid plaques in Alzheimer's disease, while donanemab is an antibody targeting a modified form of amyloid-β.

Eligible Conditions
  • Alzheimer's Disease
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Subpopulation (Superiority) on Donanemab Versus Aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab
Secondary study objectives
Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Low/Medium (Intermediate) Tau Subpopulation (Superiority) on Donanemab Versus Aducanumab
Mean Absolute Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on Donanemab Versus Aducanumab
Mean Percent Change From Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) Donanemab Versus Aducanumab

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922
23%
Amyloid related imaging abnormality-oedema/effusion
14%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
12%
Headache
7%
Superficial siderosis of central nervous system
6%
Covid-19
4%
Fall
4%
Benign prostatic hyperplasia
4%
Nausea
3%
Fatigue
3%
Infusion related reaction
3%
Gastroenteritis
3%
Nasopharyngitis
3%
Sinusitis
3%
Back pain
3%
Cataract
3%
Chest pain
3%
Dizziness
3%
Oedema peripheral
1%
Hypertensive urgency
1%
Sars-cov-2 test positive
1%
Hyponatraemia
1%
Lacunar infarction
1%
Diarrhoea
1%
Urinary tract infection
1%
Toothache
1%
Osteoarthritis
1%
Lymphocytosis
1%
Hyperlipidaemia
1%
Neck pain
1%
Muscle discomfort
1%
Asthenia
1%
Thrombocytopenia
1%
Hyperbilirubinaemia
1%
Influenza
1%
Ageusia
1%
Cough
1%
Spinal compression fracture
1%
Infusion site reaction
1%
Pain
1%
Non-cardiac chest pain
1%
Hyperglycaemia
1%
Rash erythematous
1%
Rotator cuff syndrome
1%
Epiretinal membrane peel
1%
Ejection fraction decreased
1%
Hepatic enzyme abnormal
1%
Syncope
1%
Cholecystitis
1%
Gastrooesophageal reflux disease
1%
Peripheral artery aneurysm
1%
Transient ischaemic attack
1%
Rash
1%
Vomiting
1%
Bronchitis
1%
Cerebral microhaemorrhage
1%
Nerve compression
1%
Anxiety
1%
Depressed mood
1%
Pain in extremity
1%
Benign tumour excision
1%
Atrioventricular block second degree
1%
Anaemia
1%
Haemarthrosis
1%
Infusion site extravasation
1%
Fibromyalgia
1%
Muscular weakness
1%
Bradycardia
1%
Dysphagia
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aducanumab
Donanemab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DonanemabExperimental Treatment1 Intervention
Donanemab is administered intravenously (IV) every 4 weeks (Q4W).
Group II: AducanumabActive Control1 Intervention
Aducanumab administered IV per US label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donanemab
2017
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,874 Total Patients Enrolled
Study DirectorEli Lilly and Company

Media Library

Aducanumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05108922 — Phase 3
Alzheimer's Disease Research Study Groups: Donanemab, Aducanumab
Alzheimer's Disease Clinical Trial 2023: Aducanumab Highlights & Side Effects. Trial Name: NCT05108922 — Phase 3
Aducanumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108922 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05108922 — Phase 3
~37 spots leftby Nov 2025
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