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Monoclonal Antibodies

Donanemab for Alzheimer's Disease

Verified Trial
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
You do *not* have Alzheimer's or dementia
Answer yes if you are *not* currently enrolled in another clinical trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 182
Awards & highlights

Study Summary

This trial will test a new drug, donanemab, for safety and effectiveness in people with early Alzheimer's disease.

Who is the study for?
This trial is for people aged 65-80 who are at risk of Alzheimer's but don't yet have it. Participants must be able to get an MRI and do cognitive tests, not be in another study, and have a family history of Alzheimer's or early signs of amyloid and tau pathology.Check my eligibility
What is being tested?
The trial is testing Donanemab against a placebo to see if it can prevent the onset of Alzheimer's Disease in individuals who show early signs but do not yet have symptoms. The safety and effectiveness will be evaluated.See study design
What are the potential side effects?
While specific side effects for Donanemab aren't listed here, similar drugs may cause reactions at the injection site, flu-like symptoms, headache, dizziness, nausea or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have Alzheimer's or dementia.
Select...
You can only participate in this study if you are not already taking part in another research study.
Select...
I am between 65 and 80 years old.
Select...
I am willing and able to have an MRI scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 182
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 182 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nootropic Agents
Secondary outcome measures
Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)
Change from Baseline in CDR-Sum of Boxes (CDR-SB)
Change from Baseline in Category Fluency
+9 more

Side effects data

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonanemabExperimental Treatment1 Intervention
Donanemab administered intravenously (IV)
Group II: PlaceboPlacebo Group1 Intervention
Placebo is administered intravenously
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
2,605 Previous Clinical Trials
3,197,032 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
401,207 Total Patients Enrolled

Media Library

Donanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05026866 — Phase 3
Alzheimer's Disease Research Study Groups: Donanemab, Placebo
Alzheimer's Disease Clinical Trial 2023: Donanemab Highlights & Side Effects. Trial Name: NCT05026866 — Phase 3
Donanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026866 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05026866 — Phase 3

Frequently Asked Questions

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

Has Donanemab received official government sanction for medical use?

"Donanemab has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, which means that there is evidence supporting its efficacy as well as data from multiple rounds of testing affirming its safety."

Answered by AI

Are there comparable treatments to Donanemab that have undergone clinical trials?

"At the moment, there are four ongoing clinical trials studying donanemab. Three of those studies are in phase three. Although most of the trials for donanemab are taking place in Milford, Ohio, there are a total of 684 locations running these studies."

Answered by AI

Are people still being accepted into the program?

"The latest information from clinicaltrials.gov does show that this trial is still enrolling patients. The initial posting was on 8/27/2021, with the most recent update being 11/10/2022. There are 3300 positions open across 100 different medical facilities."

Answered by AI

How many people can join this research project?

"3300 participants are required to successfully run this clinical trial. The sponsor, Eli Lilly and Company, has selected different medical sites across the country to help with recruitment. For example, Option Care - Sacramento in Sacramento, California and Care Access - Beverly Hills in Beverly Hills, Texas will both be participating."

Answered by AI

Are there many locations where this research project is taking place in town?

"Currently, there are 100 clinical trial sites operating across the nation, with locations in cities such as Sacramento, Beverly Hills, and Houston."

Answered by AI

For this particular test, are senior citizens welcome?

"This particular study is for patients aged between 65 and 80 years old. Out of the 557 clinical trials for patients over 65, this one is just 1/23rds."

Answered by AI

Do we have any other examples to compare this too?

"Donanemab has a short clinical history, with the first trial being conducted in 2020. This initial study was sponsored by Eli Lilly and Company. After this 1800-person Phase 1 study, Donanemab received approval for further testing. Currently, there are 4 active trials involving 334 cities across 9 nations."

Answered by AI

What are the Participant Inclusion Criteria for this research project?

"The eligibility criteria for this study include being 65-80 years old and having a diagnosis of Alzheimer's disease. The clinical trial is looking to enroll 3300 total patients."

Answered by AI

Who else is applying?

What state do they live in?
Florida
North Carolina
Illinois
Other
How old are they?
18 - 65
65+
What site did they apply to?
Tilda Research - USAL 45
Accellacare - Winston-Salem
Accellacare - DuPage
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
2
1
0

Why did patients apply to this trial?

I have memory issues. Want to help r research. Am former research nurse. Family history of Alzheimer’s.
PatientReceived 2+ prior treatments
Just want to prevent dimentia.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When can I start? When and where will it take place? How long does the screening take? What is involved?
PatientReceived no prior treatments
How long do screening visits take? Who is the ideal candidate for this trial?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Tilda Research - USAL 45: < 48 hours
  2. Accellacare - DuPage: < 48 hours
  3. Accellacare - Winston-Salem: < 48 hours
~1496 spots leftby Oct 2027