BridgeMD
A Study to Learn About the Safety of BIIB080 and Whether it Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer’s Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (CELIA)
EU CTIS ID: 2022-501644-15-01
What this study is testing
Objectives and Endpoints for Placebo-Controlled Period: To characterize the dose-response in change from Baseline to Week 76 using Clinical Dementia Rating-Sum of Boxes (CDR-SB).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Key Inclusion Criteria for Placebo-controlled Period: Must meet all the clinical 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) and must have the following at Screening Visit 1: 1) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index score of ≤85, indicative of objective evidence of memory impairment 2) CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia 3) MMSE score of 21 to 30 (inclusive) 4) CDR Memory Box score of ≥0.5 Key Inclusion Criteria for LTE Period: • Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), where local regulations and institutional practices permit, as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. Incapacitated individuals will not be enrolled in the EU and other countries where local laws, regulations, and practices do not permit their inclusion. • Participants must have completed the placebo-controlled period of the study, including Week 76 visit. • Participants must have taken at least 5 doses of BIIB080 or placebo during the placebo-controlled period. • • Medically able to undergo the study procedures (including LP [lumbar puncture]) and to adhere to the visit schedule at the time of study entry into the LTE period, as determined by the investigator. • Apart from a clinical diagnosis of AD, the participant must be in good health as determined by the investigator, based on medical history. • Must have 1 care partner who, in the Investigator’s judgment, has frequent and sufficient contact with the participant (at least 10 hours/week) to be able to provide accurate information about the participant’s cognitive and functional abilities.
- Evidence of amyloid pathology as measured by positive emission tomography (PET) or cerebrospinal fluid (CSF) sampling
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
You likely can't join if
- Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product
- Current use or previous use of medications with a purported disease‑modifying effect in AD, outside of investigational studies
- Any vaccination given within 10 days prior to Day -1. Coronavirus disease 2019 (COVID-19) vaccinations using RNA or deoxyribonucleic acid (DNA) technology are allowed during the study, as well as other types of immunization /vaccination/ booster, except during the 10 days before and after clinic visits
- Contraindications to having a brain magnetic resonance imaging (MRI) [e.g., MRI-incompatible pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed]. If the MRI compatibility of implanted devices is unknown, the participant must be excluded from the study
- Current enrolment or a plan to enrol in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 52 weeks prior to the Baseline Visit
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
See the full eligibility criteria
Who can join
- Key Inclusion Criteria for Placebo-controlled Period: Must meet all the clinical 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) and must have the following at Screening Visit 1: 1) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index score of ≤85, indicative of objective evidence of memory impairment 2) CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia 3) MMSE score of 21 to 30 (inclusive) 4) CDR Memory Box score of ≥0.5 Key Inclusion Criteria for LTE Period: • Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), where local regulations and institutional practices permit, as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. Incapacitated individuals will not be enrolled in the EU and other countries where local laws, regulations, and practices do not permit their inclusion. • Participants must have completed the placebo-controlled period of the study, including Week 76 visit. • Participants must have taken at least 5 doses of BIIB080 or placebo during the placebo-controlled period. • • Medically able to undergo the study procedures (including LP [lumbar puncture]) and to adhere to the visit schedule at the time of study entry into the LTE period, as determined by the investigator. • Apart from a clinical diagnosis of AD, the participant must be in good health as determined by the investigator, based on medical history. • Must have 1 care partner who, in the Investigator’s judgment, has frequent and sufficient contact with the participant (at least 10 hours/week) to be able to provide accurate information about the participant’s cognitive and functional abilities.
- Evidence of amyloid pathology as measured by positive emission tomography (PET) or cerebrospinal fluid (CSF) sampling
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
What rules you out
- Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product
- Current use or previous use of medications with a purported disease‑modifying effect in AD, outside of investigational studies
- Any vaccination given within 10 days prior to Day -1. Coronavirus disease 2019 (COVID-19) vaccinations using RNA or deoxyribonucleic acid (DNA) technology are allowed during the study, as well as other types of immunization /vaccination/ booster, except during the 10 days before and after clinic visits
- Contraindications to having a brain magnetic resonance imaging (MRI) [e.g., MRI-incompatible pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed]. If the MRI compatibility of implanted devices is unknown, the participant must be excluded from the study
- Current enrolment or a plan to enrol in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 52 weeks prior to the Baseline Visit
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
- Key Exclusion Criteria for LTE Period • Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant’s enrolment in and completion of the study.
- Previous participation in this study or previous studies with BIIB080
- Use of non-disease–modifying AD medications (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1
- Use of any commercially available disease-modifying AD medications such as anti-amyloid monoclonal antibodies.
- Prior participation in any active or passive immunotherapy study targeting Aβ, unless documentation of receipt of placebo is available
- Prior participation in any passive immunotherapy study targeting tau, unless the last administration occurred 6 months or 5 half-lives, whichever is sooner, prior to Screening or documentation of receipt of placebo is available
- Prior participation in any study involving an investigational treatment targeting tau that is not an immunotherapy, unless documentation of receipt of placebo is available
- Prior participation in a study of any gene therapy with a purported disease‑modifying effect in AD, unless documentation of receipt of placebo is available
- Prior participation in a study of any other agent(s) [including gene therapy] not included in exclusion criteria 4, 5, and 6 with a purported disease‑modifying effect in AD, unless documentation of receipt of placebo is available
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Japan
- United Kingdom
- Australia
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Japan; United Kingdom; Australia; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.