BIIB080 for Alzheimer's Disease

(CELIA Trial)

Recruiting at 139 trial locations

Overseen By Stephen Flitman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biogen

Must not be taking: Anti-amyloid antibodies

Disqualifiers: Allergy to BIIB080, Unstable AD meds, MRI contraindications, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

416 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. * Clinicians use the CDR-SB to measure several categories of dementia symptoms. * The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of BIIB080. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension (LTE) Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. * After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. * Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks. * After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. * In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks. * Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. * Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. * After the screening period, most participants will visit the clinic every 6 weeks.

Do I need to stop my current medications to join the trial?

You can continue taking certain Alzheimer's medications, but you must be on the same dose for at least 8 weeks before the screening period. However, you cannot use any disease-modifying Alzheimer's medications or participate in other investigational studies during the trial.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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.

Inclusion Criteria

Your memory test score is less than or equal to 85, showing that you have memory problems.

Your CDR Memory Box score is at least 0.5.

I have a family history or diagnosis of Mild Cognitive Impairment or Alzheimer's.

Exclusion Criteria

I have a history of a bleeding disorder.

Are you currently using cannabis (in any form, by prescription or recreation) ?

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-Controlled Period

Participants receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the cerebrospinal fluid every 12 or 24 weeks

76 weeks

Clinic visits every 6 weeks

Long-Term Extension (LTE) Period

Eligible participants continue to receive BIIB080 to assess long-term safety and effects on daily life, thinking, and memory

96 weeks

Injections every 12 or 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BIIB080
• BIIB080-matching placebo

Trial Overview 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.

Participant Groups

Group I: BIIB080 Low Dose Q24W Experimental Treatment 2 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 Q24W Experimental Treatment 2 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 Q12W Experimental Treatment 1 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 Q12W Placebo Group 2 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.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada