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Monoclonal Antibodies

Aducanumab for Alzheimer's Disease

Phase 3
Waitlist Available
Research Sponsored by Biogen
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 up to week 100
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of aducanumab, a drug for Alzheimer's disease, over 100 weeks. There is a wash-out period for participants who have previously received aducanumab or placebo.

Who is the study for?
This trial is for individuals with Alzheimer's who were part of previous aducanumab studies. They must have finished the initial study period, tolerated a specific dose well, and have a care partner to report on their cognitive abilities. People with recent serious health issues or certain medical conditions are excluded.Check my eligibility
What is being tested?
The trial tests the safety and tolerability of aducanumab in people with Alzheimer's over 100 weeks after they've had a break from earlier related trials. It includes those who previously received aducanumab as well as those who initially got a placebo.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of aducanumab may include reactions at the injection site, headaches, falls, diarrhea or other digestive issues, and potential changes in mental status.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 100 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum
Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal
Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
+2 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%
Nasopharyngitis
3%
Constipation
3%
Vertigo
3%
Anxiety
3%
Dyspnoea
3%
Upper respiratory tract infection
1%
Hypertonic bladder
1%
Pericardial effusion
1%
Back pain
1%
Gout
1%
Urinary tract infection
1%
Mental status changes
1%
Nephrolithiasis
1%
Infusion site reaction
1%
Macular hole
1%
Tooth infection
1%
Affective disorder
1%
Pneumothorax
1%
Sepsis
1%
Chest pain
1%
Feeling abnormal
1%
Food poisoning
1%
Gastritis
1%
Pruritus
1%
Aspartate aminotransferase increased
1%
Deep vein thrombosis
1%
Skin laceration
1%
Meniere's disease
1%
Hypersensitivity
1%
Pain in extremity
1%
Pulmonary embolism
1%
Diverticulitis
1%
Onychomycosis
1%
Rib fracture
1%
Syncope
1%
Gastrooesophageal reflux disease
1%
Insomnia
1%
Sinusitis
1%
Tooth abscess
1%
Basal cell carcinoma
1%
Campylobacter infection
1%
Ear infection
1%
Ingrowing nail
1%
Dry skin
1%
Knee arthroplasty
1%
Diarrhoea
1%
Oedema peripheral
1%
Nausea
1%
Palpitations
1%
Alanine aminotransferase increased
1%
Hypotension
1%
Fall
1%
Abdominal discomfort
1%
Large intestinal polypectomy
1%
Tachycardia
1%
Disturbance in attention
1%
Hypertriglyceridaemia
1%
Cough
1%
Pneumomediastinum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab
Aducanumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: AducanumabExperimental Treatment1 Intervention
Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aducanumab
2022
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
465,740 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,061,784 Total Patients Enrolled

Media Library

Aducanumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04241068 — Phase 3
Alzheimer's Disease Research Study Groups: Aducanumab
Alzheimer's Disease Clinical Trial 2023: Aducanumab Highlights & Side Effects. Trial Name: NCT04241068 — Phase 3
Aducanumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04241068 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04241068 — Phase 3

Frequently Asked Questions

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

Do you have an age limit for participants in this research?

"This specific medical trial is searching for individuals that are 50 years old or above, and younger than 90 years old."

Answered by AI

When will Aducanumab receive full regulatory approval?

"Aducanumab was given a safety score of 3 by our team at Power. This is because Aducanumab is currently in Phase 3 trials, which implies that there is some evidence suggesting the medication's efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Are there any other drugs that have been studied in combination with Aducanumab?

"Aducanumab was first researched at Wake Forest Baptist Health in 2020. So far, 5 studies have been completed while 2 are ongoing. These active trials are based in New york City."

Answered by AI

Have other similar investigations been done in the past?

"Research into Aducanumab began in 2020 with a study sponsored by Biogen. After the initial Phase 3 clinical trial, which had 1696 participants, the drug received approval. As of now, there are 2 ongoing studies involving Aducanumab being conducted in 202 cities across 20 countries."

Answered by AI

Are there specific individuals that this clinical trial is meant for?

"This trial is enrolling 1696 patients with Alzheimer's disease who are between the ages of 50 and 90. The following criteria must also be met: Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies)., Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities., Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of"

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Texas
Other
Colorado
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
University of Alabama at Birmingham
NeuroStudies.net, LLC
ActivMed Practices & Research, Inc.
Other

Why did patients apply to this trial?

I will trail this medication. I've only been been prescribed 1 drug as treatment.
PatientReceived 1 prior treatment
I'm interested in any trials that may advance the battle againsy AD. I have mild cognitive impairment. I’m interested in a trial to slow progression of disease.
PatientReceived 2+ prior treatments
I was in phase 3 clinical trial for Aducanumab at RI Hospital and had excellent results. I was in trial a few years and never experienced any problems. I was randomized to the 10mg dosage from the beginning which was very well tolerated by me.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does screening take? How long do screening take it?
PatientReceived 1 prior treatment
~334 spots leftby Apr 2025