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Monoclonal Antibodies

Donanemab for Early 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 baseline, up to week 76
Awards & highlights

Study Summary

This trial is studying how safe and effective donanemab is in treating early Alzheimer's disease.

Who is the study for?
This trial is for people with early Alzheimer's who've had memory changes for at least 6 months, scoring 20-28 on the MMSE (a cognitive test). They must meet specific criteria on PET scans and have a partner to consent to participate. Those who can't undergo MRI or PET scans or are currently on IgG therapy cannot join.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Donanemab in treating early Alzheimer's disease. Participants will either receive Donanemab or a placebo. An additional group will be openly given Donanemab to assess its safety further.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system activation, as it is common with monoclonal antibodies like Donanemab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS)
Secondary outcome measures
Brain
Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI)
+6 more

Side effects data

From 2023 Phase 3 trial • 148 Patients • NCT05108922
21%
Amyloid related imaging abnormality-oedema/effusion
14%
Covid-19
14%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
8%
Headache
7%
Infusion related reaction
4%
Arthralgia
4%
Dizziness
3%
Pneumonia
3%
Vertigo
3%
Nasopharyngitis
3%
Constipation
3%
Anxiety
3%
Upper respiratory tract infection
3%
Dyspnoea
1%
Infusion site reaction
1%
Tooth infection
1%
Macular hole
1%
Affective disorder
1%
Mental status changes
1%
Ingrowing nail
1%
Chest pain
1%
Pericardial effusion
1%
Urinary tract infection
1%
Feeling abnormal
1%
Food poisoning
1%
Gastritis
1%
Aspartate aminotransferase increased
1%
Deep vein thrombosis
1%
Meniere's disease
1%
Hypersensitivity
1%
Pulmonary embolism
1%
Diverticulitis
1%
Rib fracture
1%
Gastrooesophageal reflux disease
1%
Insomnia
1%
Sinusitis
1%
Tooth abscess
1%
Campylobacter infection
1%
Dry skin
1%
Knee arthroplasty
1%
Diarrhoea
1%
Oedema peripheral
1%
Nausea
1%
Alanine aminotransferase increased
1%
Hypotension
1%
Fall
1%
Abdominal discomfort
1%
Disturbance in attention
1%
Skin laceration
1%
Hypertonic bladder
1%
Pneumothorax
1%
Onychomycosis
1%
Hypertriglyceridaemia
1%
Ear infection
1%
Large intestinal polypectomy
1%
Basal cell carcinoma
1%
Gout
1%
Nephrolithiasis
1%
Syncope
1%
Palpitations
1%
Cough
1%
Back pain
1%
Pneumomediastinum
1%
Pain in extremity
1%
Sepsis
1%
Tachycardia
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab
Aducanumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonanemabExperimental Treatment1 Intervention
Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo given IV.
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
2,622 Previous Clinical Trials
3,215,039 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
414,162 Total Patients Enrolled

Media Library

Donanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04437511 — Phase 3
Alzheimer's Disease Research Study Groups: Donanemab, Placebo
Alzheimer's Disease Clinical Trial 2023: Donanemab Highlights & Side Effects. Trial Name: NCT04437511 — Phase 3
Donanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437511 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04437511 — Phase 3

Frequently Asked Questions

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

Are we able to sign up for this trial right now?

"This particular clinical trial is not currently recruiting patients. However, it was initially posted on 6/19/20 and edited as recently as 8/3/22. If you are interested in other studies, 562 clinical trials for alzheimer disease and 4 studies for Donanemab are actively searching for participants."

Answered by AI

Does this clinical trial have an age limit? If so, what is the maximum age of participants?

"The age limit for candidates eligible for this trial are between 60 to 85 years old."

Answered by AI

How many different medical facilities are running this clinical trial?

"There are 100 recruiting patients for this study such as Sensible Healthcare, LLC in Ocoee, Senior Adults Specialty Research in Austin, and Arch Clinical Trials, LLC in Saint Louis."

Answered by AI

What is the current regulatory status of Donanemab?

"Donanemab has received a 3 for safety from our team at Power. This is because it is a Phase 3 trial, and there is thus some data supporting efficacy as well as multiple rounds of data affirming safety."

Answered by AI

How many patients are currently enrolled in this trial?

"Unfortunately, this study is not enrolling patients at the moment. The listing was created on June 19th 2020 and updated as recently as August 3rd 2022. There are 562 other trials for patients with Alzheimer's disease that are still recruiting participants along with 4 clinical trials for Donanemab."

Answered by AI

Can you provide some context for this Donanemab study by detailing other research that has been conducted in the past?

"Donanemab was first studied in 2020 for its efficacy in treating Parkinson's disease and Movement Disorders. Since then, there have been 18290 completed clinical trials worldwide. As of now, there are 4 live studies-- a significant number of which are based out of Ocoee, Texas."

Answered by AI

To whom does this study's eligibility requirements apply?

"The target population for this study are those aged 60 to 85 who have Alzheimer's disease. Out of these patients, 1800 will be enrolled. Furthermore, it is a requirement that they have a Mini-Mental State Examination (MMSE) score between 20 and 28 at the start of the trial as well as having had gradual changes in their memory function over a period of at least six months."

Answered by AI

Has a clinical trial like this been conducted before?

"There are 4 ongoing clinical trials for Donanemab in 334 cities across 9 countries. The very first study was completed in 2020 and it received Phase 3 drug approval. Since then, 18290 more trials have been completed."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Pennsylvania
Florida
Other
How old are they?
18 - 65
65+
What site did they apply to?
ARS- Neurology and Neurodiagnostics of Alabama
Suncoast Neuroscience Associates
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

What % will be placebos?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have mild memory loss. Have not tried any drugs. Just starting clinical trial research.
PatientReceived no prior treatments
I am worried about getting Alzheimer’s or dementia as my mother suffered from it.
PatientReceived 1 prior treatment
I take donezil and it isn’t helping. I am told by several people including my husband that I repeat myself.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
2020. "A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04437511.
All > Alzheimer Disease > Alzheimers Disease
~359 spots leftby May 2025
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