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Monoclonal Antibodies

BIIB080 for Alzheimer's Disease (CELIA Trial)

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Do you have a care/study partner who can attend all visits with you?

Are you comfortable with receiving an intrathecal injection during a lumbar puncture of the study drug/placebo?

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

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have someone who can come to all my appointments with me.

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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:

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I have not had a stroke in the past year or a seizure in the last 10 years.

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I do not have any neurodegenerative diseases other than Alzheimer's or serious brain infections.

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I have a bleeding disorder or a past MRI showed I had a hemorrhage.

Timeline

Screening ~ 63 days3 visits

Treatment ~ 18 months18 visits

Follow Up ~ 5 months0 visits

Screening ~ 63 days

Treatment ~ 18 months

Follow Up ~5 months

This trial's timeline: 63 days for screening, 18 months for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose response in Change From Baseline to Week 76 on the CDR-SB

Secondary study objectives

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 more

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, Q24W from Week 1 up to 72 weeks and BIIB080-matching placebo, IT injection, once at Weeks 12, 36, and 60 during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 low dose, IT injection, Q24W for an additional 96 weeks.

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 during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 high dose, IT injection, Q24W for an additional 96 weeks.

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 during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 high dose, IT injection, Q12W for an additional 96 weeks.

Group IV: Placebo Q12WPlacebo Group2 Interventions

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, during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will be randomized to receive BIIB080 high dose, IT injection, either Q12W or once every 24 weeks (Q24W) for an additional 96 weeks.

0 / 7Eligibility criteria met