BIIB080 for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kingfisher Cooperative, LLC, Spokane, WA
Alzheimer's Disease+4 More
BIIB080 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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. A description of how the study will be done is given below. Participants will receive either a low dose or high dose of BIIB080 or a placebo as an injection into the fluid around the spinal cord. A placebo looks like the study drug but contains no real medicine. The fluid around the spinal cord is called the cerebrospinal fluid. Participants will be in the study for 105 weeks, or a little over 2 years. This includes the screening and follow-up periods. Participants will be given BIIB080 or placebo once every 12 weeks for a total of 72 weeks. 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.

Eligible Conditions

  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer's Disease

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 105 weeks

Baseline to Week 76
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)
Change From Baseline to Week 76 on the CDR-SB
Change From Baseline to Week 76 on the Mini Mental State Examination (MMSE)
Change From Baseline to Week 76 on the Modified Integrated Alzheimer's Disease Rating Scale (iADRS)
Dose-response in Change From Baseline to Week 76 on the CDR-SB
Up to 105 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Alzheimer's Disease

Trial Design

4 Treatment Groups

BIIB080 Low Dose Q24W
1 of 4
BIIB080 High Dose Q24W
1 of 4
BIIB080 High Dose Q12W
1 of 4
Placebo Q12W
1 of 4
Experimental Treatment
Non-Treatment Group

735 Total Participants · 4 Treatment Groups

Primary Treatment: BIIB080 · Has Placebo Group · Phase 2

BIIB080 Low Dose Q24WExperimental Group · 2 Interventions: BIIB080, BIIB080-matching placebo · Intervention Types: Drug, Drug
BIIB080 High Dose Q24WExperimental Group · 2 Interventions: BIIB080, BIIB080-matching placebo · Intervention Types: Drug, Drug
BIIB080 High Dose Q12W
Drug
Experimental Group · 1 Intervention: BIIB080 · Intervention Types: Drug
Placebo Q12W
Drug
PlaceboComparator Group · 1 Intervention: BIIB080-matching placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 105 weeks
Closest Location: Kingfisher Cooperative, LLC · Spokane, WA
Photo of spokane 1Photo of spokane 2Photo of spokane 3
2018First Recorded Clinical Trial
0 TrialsResearching Alzheimer's Disease
3 CompletedClinical Trials

Who is running the clinical trial?

BiogenLead Sponsor
550 Previous Clinical Trials
441,708 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,597 Previous Clinical Trials
8,930,610 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a RBANS Delayed Memory Index score of ≤85, indicative of objective evidence of memory impairment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.