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Monoclonal Antibodies
BIIB080 for Alzheimer's Disease (CELIA Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must meet all the clinical staging criteria for MCI due to AD (Stage 3) or mild AD dementia (Stage 4) according to the National Institute on Aging at National Institutes of Health and the Alzheimer's Association (NIA-AA)
Do you have a care/study partner who can attend all visits with you?
Must not have
Have you had a stroke within the past year or a seizure within the last 10 years?
Do you have any other neurodegenerative disease aside from Alzheimer's or serious infection of the brain?
Timeline
Screening 63 days
Treatment 18 months
Follow Up 5 months
Awards & highlights
CELIA Trial Summary
This trial is testing a study drug called BIIB080 for people with mild cognitive impairment or mild dementia due to AD. The goal is to see if the drug can slow the worsening of AD more than placebo.
Who is the study for?
This trial is for people aged 50-80 with mild cognitive impairment or mild Alzheimer's dementia, who have certain scores on memory and cognition tests, evidence of amyloid in the brain, and stable use of Alzheimer's medications. Excluded are those allergic to BIIB080, previously treated with it or other specific Alzheimer's therapies, unstable medication doses, recent vaccinations around clinic visits, MRI contraindications.Check my eligibility
What is being tested?
Researchers are testing if BIIB080 can slow down Alzheimer's disease progression compared to a placebo. Participants will receive either a low or high dose of BIIB080 injected into their spinal fluid every 12 weeks for over two years while being monitored using the CDR-SB score that assesses dementia symptoms.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions due to injections into the cerebrospinal fluid which could include local pain or discomfort and potential drug-related effects.
CELIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is either mild cognitive impairment or mild Alzheimer's dementia.
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I have someone who can come to all my appointments with me.
Select...
I am comfortable receiving an injection in my spine for the study.
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I have a family history or diagnosis of Mild Cognitive Impairment or Alzheimer's.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a stroke in the past year or a seizure in the last 10 years.
Select...
I do not have any neurodegenerative diseases other than Alzheimer's or serious brain infections.
Select...
I have a bleeding disorder or a past MRI showed I had a hemorrhage.
CELIA Trial Timeline
Screening ~ 63 days3 visits
Treatment ~ 18 months18 visits
Follow Up ~ 5 months0 visits
Screening ~ 63 days
Treatment ~ 18 months
Follow Up ~5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-response in Change From Baseline to Week 76 on the CDR-SB
Secondary outcome measures
Change From Baseline to Week 76 on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 13)
Change From Baseline to Week 76 on the Alzheimer's Disease Composite Score (ADCOMS)
Change From Baseline to Week 76 on the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI)
+4 moreCELIA Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB080 Low Dose Q24WExperimental Treatment2 Interventions
Participants will receive a low dose of BIIB080, IT injection, once every 24 weeks (Q24W) from Week 1 up to 72 weeks and BIIB080-matching placebo, IT injection, once at Weeks 12, 36 and 60.
Group II: BIIB080 High Dose Q24WExperimental Treatment2 Interventions
Participants will receive a high dose of BIIB080, IT injection, Q24W from Week 1 up to 72 weeks and BIIB080-matching placebo, IT injection, once at Weeks 12, 36 and 60.
Group III: BIIB080 High Dose Q12WExperimental Treatment1 Intervention
Participants will receive a high dose of BIIB080, IT injection, once on Day 1 and then Q12W for up to 72 weeks.
Group IV: Placebo Q12WPlacebo Group1 Intervention
Participants will receive BIIB080-matching placebo, intrathecal (IT) injection, once on Day 1 and then once every 12 weeks (Q12W) for up to 72 weeks.
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
466,587 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,484 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 63 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 18 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 5 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Biogen's BIIB080 come with any serious side effects?
"There is some evidence indicating that BIIB080 is safe for use, but not efficacy, so it was given a 2."
Answered by AI
Does this trial have any age restrictions?
"This research is enrolling patients that are over the age of 50 but under 80 years old."
Answered by AI
Are volunteers currently being accepted for this experiment?
"This trial, which was created on 8/24/2022 and updated on 11/11/2022 according to clinicaltrials.gov, is looking for participants."
Answered by AI
How many people can join this trial at its largest?
"In order to carry out the study, 735 patients that meet the inclusion criteria will be needed. The sponsor of the trial, Biogen, plans to use various sites including AMC Research in Matthews, North carolina and Butler Hospital in Providence, Rhode island."
Answered by AI
Where can patients enroll in this trial?
"There are 10 total centres where this trial is taking place, 5 of which are active. These include AMC Research, LLC in Matthews, Butler Hospital in Providence, and Kingfisher Cooperative, LLC in Spokane."
Answered by AI
Would I be a good candidate to participate in this research study?
"This Alzheimer's study is looking for 735 people aged 50-80. In addition to having a diagnosis of Alzheimer's, patients must also have a CDR global score of 0.5 or 1, an MMSE score of 22-30, a positive PET scan or CSF sampling for amyloid pathology, and evidence of memory impairment as measured by the RBANS Delayed Memory Index."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Butler Hospital
University of Texas Health Science Center at San Antonio
Xenoscience Inc.
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
What questions have other patients asked about this trial?
How many screenings will there be and how long will each one take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Xenoscience Inc.: < 24 hours
Average response time
- < 1 Day
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