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Monoclonal Antibodies
Aducanumab for Alzheimer's Disease (ENVISION Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
Must have memory concerns and/or a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
Must not have
Have you had a stroke or heart attack in the last 12 months?
Timeline
Screening 60 days
Treatment 104 weeks
Follow Up 18 weeks
Awards & highlights
ENVISION Trial Summary
This trial is testing whether a drug called aducanumab can slow down cognitive and functional decline in people with early Alzheimer's disease, as measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score.
Who is the study for?
This trial is for people with early Alzheimer's disease who have confirmed amyloid beta pathology, an MMSE score of 22-30, and a reliable informant. They must be in good health aside from Alzheimer's and not on cognition-affecting meds or those with antiplatelet properties. Prior aducanumab users are excluded.Check my eligibility
What is being tested?
The study tests if monthly doses of aducanumab can slow cognitive and functional decline compared to placebo in early Alzheimer's patients, measured by the CDR-SB score changes over time.See study design
What are the potential side effects?
Aducanumab may cause infusion reactions, headaches, falls, diarrhea or constipation. It might also lead to swelling or bleeding in the brain which can manifest as confusion, dizziness or nausea.
ENVISION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on any long-term medications that affect my thinking.
Select...
I am not taking any blood thinners, except for aspirin.
Select...
I have not had a serious mental health issue in the last 6 months.
Select...
I have someone who knows about my health and can talk about it for at least 10 hours a week.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a stroke or heart attack in the last 12 months.
ENVISION Trial Timeline
Screening ~ 60 days4 visits
Treatment ~ 104 weeks30 visits
Follow Up ~ 18 weeks1 visit
Screening ~ 60 days
Treatment ~ 104 weeks
Follow Up ~18 weeks
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 in CDR-SB Score at Week 78
Secondary outcome measures
Change From Baseline in ADAS-Cog13 Score at Weeks 78 and 106
Change From Baseline in ADCS-ADL-MCI Score at Weeks 78 and 106
Positron-Emission Tomography
+6 moreSide effects data
From 2023 Phase 3 trial • 148 Patients • NCT0510892221%
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%
Pneumonia
3%
Vertigo
3%
Constipation
3%
Anxiety
3%
Dyspnoea
3%
Nasopharyngitis
3%
Upper respiratory tract infection
1%
Infusion site reaction
1%
Tooth infection
1%
Chest pain
1%
Campylobacter infection
1%
Macular hole
1%
Affective disorder
1%
Pericardial effusion
1%
Urinary tract infection
1%
Feeling abnormal
1%
Food poisoning
1%
Gastritis
1%
Aspartate aminotransferase increased
1%
Deep vein thrombosis
1%
Basal cell carcinoma
1%
Mental status changes
1%
Pulmonary embolism
1%
Rib fracture
1%
Insomnia
1%
Sinusitis
1%
Tooth abscess
1%
Dry skin
1%
Diarrhoea
1%
Oedema peripheral
1%
Nausea
1%
Diverticulitis
1%
Pruritus
1%
Knee arthroplasty
1%
Large intestinal polypectomy
1%
Alanine aminotransferase increased
1%
Hypotension
1%
Fall
1%
Abdominal discomfort
1%
Disturbance in attention
1%
Hypertonic bladder
1%
Onychomycosis
1%
Hypertriglyceridaemia
1%
Ear infection
1%
Ingrowing nail
1%
Nephrolithiasis
1%
Syncope
1%
Palpitations
1%
Cough
1%
Skin laceration
1%
Back pain
1%
Pneumothorax
1%
Pneumomediastinum
1%
Pain in extremity
1%
Sepsis
1%
Tachycardia
1%
Meniere's disease
1%
Gastrooesophageal reflux disease
1%
Gout
1%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab
Aducanumab
ENVISION Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AducanumabExperimental Treatment1 Intervention
Participants will receive aducanumab, up to 10 milligrams per kilograms (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.
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
465,633 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,790 Previous Clinical Trials
8,066,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with early Alzheimer's or mild cognitive impairment due to Alzheimer's.I am not on any long-term medications that affect my thinking.I do not have any uncontrolled health conditions affecting my brain function, aside from Alzheimer's.There may be additional requirements or restrictions for participating in this study that are not listed here.You have noticed a slow and gradual decline in your memory over the past 6 months, and your study partner confirms this.You must have noticed a gradual decline in your memory over the past six months, and your study partner must confirm this.I have early Alzheimer's but am otherwise in good health.You are currently using a drug that is not yet approved by regulatory agencies.I have used Alzheimer's disease-modifying medications outside of a study.I have not had a serious mental health issue in the last 6 months.I have someone who knows about my health and can talk about it for at least 10 hours a week.I am not taking any blood thinners, except for aspirin.I am not on any long-term medications that affect my thinking.I have been diagnosed with early Alzheimer's or mild cognitive impairment due to Alzheimer's.You have a memory score of at least 0.5.\nI have not had a stroke or heart attack in the last 12 months.I agree to genetic testing for ApoE.I have been part of a study or used aducanumab before but did not actually receive the drug.I have not had a stroke, mini-stroke, or unexplained fainting in the last year.You have a history of severe allergic reactions or hypersensitivity to any of the non-active ingredients in the drug.I have never been treated with aducanumab before.
Research Study Groups:
This trial has the following groups:- Group 1: Aducanumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 60 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 104 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 18 Weeks after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05310071 — Phase 3
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