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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 below
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I am not on any long-term medications that affect my thinking.
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I am not taking any blood thinners, except for aspirin.
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I have not had a serious mental health issue in the last 6 months.
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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 days
Treatment ~ 104 weeks
Follow Up ~18 weeks
This trial's timeline: 60 days for screening, 104 weeks for treatment, and 18 weeks 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 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 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%
Upper respiratory tract infection
3%
Dyspnoea
1%
Pericardial effusion
1%
Infusion site reaction
1%
Macular hole
1%
Tooth infection
1%
Affective disorder
1%
Pneumothorax
1%
Ingrowing nail
1%
Mental status changes
1%
Chest pain
1%
Feeling abnormal
1%
Food poisoning
1%
Gastritis
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%
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%
Tachycardia
1%
Disturbance in attention
1%
Sepsis
1%
Onychomycosis
1%
Urinary tract infection
1%
Hypertonic bladder
1%
Hypertriglyceridaemia
1%
Ear infection
1%
Large intestinal polypectomy
1%
Basal cell carcinoma
1%
Gout
1%
Nephrolithiasis
1%
Pruritus
1%
Syncope
1%
Palpitations
1%
Cough
1%
Back pain
1%
Pneumomediastinum
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
465,810 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,062,376 Total Patients Enrolled

Media Library

Aducanumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05310071 — Phase 3
Alzheimer's Disease Research Study Groups: Aducanumab, Placebo
Alzheimer's Disease Clinical Trial 2023: Aducanumab Highlights & Side Effects. Trial Name: NCT05310071 — Phase 3
Aducanumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05310071 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05310071 — Phase 3

Frequently Asked Questions

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

Has Aducanumab been approved by the FDA for clinical use?

"With a score of 3, Aducanumab is considered to be relatively safe due to the existence of efficacy data and multiple safety studies."

Answered by AI

What criteria must be met in order to participate in this scientific experiment?

"This investigation is seeking 1,512 individuals aged between 60 and 85 who have been diagnosed with Alzheimer's disease (AD). Moreover, these participants must fulfill the following criteria: verified amyloid beta pathology by cerebrospinal fluid or PET scan; self-reported gradual memory decline in the six months prior to screening; a minimum of 10 hours contact per week with an informant/care partner for accurate information sharing about cognitive and functional abilities over time; National Institute on Aging – Alzheimer’s Association diagnosis of Mild cognitive impairment due to AD or mild AD; Mini Mental State Examination score between 22 and 30 inclusive; Clinical Dement"

Answered by AI

Is the eligibility criteria for this trial limited to people under 35 years of age?

"This medical trial requires participants to be aged between 60 and 85 years old. For those under 18, there are 23 clinical trials available; conversely, for applicants over 65 538 studies exist."

Answered by AI

Are individuals currently being accepted for participation in this medical trial?

"Affirmative. Clinicaltrials.gov has data that shows this clinical trial is now recruiting participants, having been first posted on June 2nd 2022 and last updated November 30th of the same year. The researchers need 1512 individuals at 50 different sites to join the study."

Answered by AI

How many hospitals are participating in this scientific experiment?

"This clinical trial is being implemented across 50 sites. Major cities like New Haven, Sun City and Fresno are included in this list of locations. It would be ideal to select the medical centre closest to you if you choose to participate, so as to reduce travel costs."

Answered by AI

How many participants are enrolled in this research project?

"To execute the study, Biogen needs 1512 qualified patients. It is being administrated by two major medical centres - Institute for Neurodegenerative Diseases in New Haven and Banner Sun Health Research Institute in Sun City."

Answered by AI

Who else is applying?

What state do they live in?
New York
Rhode Island
Other
Massachusetts
How old are they?
65+
What site did they apply to?
New York University Medical Center PRIME
Yale University School Of Medicine
McLean Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

My mom had Alzheimer’s. Earn $$$. Improve memory. Looking for help with MCI.
PatientReceived 2+ prior treatments
I'm tired of living with alz. In initial stage of research.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When would I be able to come in? Are there any Remote Home Study Trials?? Have MCI. How long are trials? What’s required?
PatientReceived 2+ prior treatments
How long do visits take, and what is the duration of the trial?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Institute for Neurodegenerative Diseases: < 24 hours
  2. New York University Medical Center PRIME: < 24 hours
  3. K2 Medical Research, LLC: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
2022. "A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05310071.
All > Alzheimers Disease Dallas > Honolulu
~720 spots leftby Dec 2025
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