CELIA

A randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of BIIB080 in subjects with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia

Conditions

Sponsor

Biogen

Clinical Trial

Status

Drug

BIIB080

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Cerebrospinal fluid injection. Cerebrospinal fluid is the fluid around the spinal cord.

Participants will be selected by chance to receive one of the following options:

A low dose of BIIB080
A high dose of BIIB080
Placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect)

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

The main question researchers are trying to answer is if BIIB080 can slow the worsening of Alzheimer's disease more than placebo. It will focus on what dose of BIIB080 slows worsening of Alzheimer’s disease 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 about the safety of BIIB080.

The study will be split into two parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension Period
After screening, participants will first receive either BIIB080 (low or high dose) or a 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
After the screening period, most participants will visit the clinic every 6 weeks.

During the study, participants will be asked:

To complete tests that will assess their cognition, memory and orientation (i.e. CDR, RBANS, MMSE)
To undergo lumbar puncture (CSF) or brain scans (PET).

Further information on the procedures, tests and number of visits can be obtained from the study team.

To take part in the Placebo-Controlled Period, key inclusion criteria for participants are:

Be between 50 and 80 years old
Have a diagnosis for mild cognitive impairment due to Alzheimer's disease (stage 3) or mild Alzheimer's disease 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:
Have a Delayed Memory Index score of ≤85 in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), indicative of objective evidence of memory impairment
Have a score of 0.5 for Mild Cognitive Impairment due to Alzheimer’s disease or 1 for mild Alzheimer’s disease dementia in the Clinical Dementia Rating-Global Score (CDR)
Have a score of 21-30 (inclusive) points in the MMSE test (a test about a range of everyday mental skills)
Have a score of ≥0.5 in the CDR Memory Box
Have evidence of amyloid pathology as measured by positive emission tomography (PET) or cerebrospinal fluid (CSF) sampling
Have a study partner who 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.

To take part in the Long-Term Extension Period, key inclusion criteria for participants are:

Have completed the placebo-controlled period of the study, including the Week 76 visit
Have taken at least 5 doses of BIIB080 or placebo during the placebo-controlled period
Have a MMSE score >10 at the Week 76 visit
Have a study partner who 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.

Exclusion criteria for the Placebo-controlled period include:

Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product
Previous participation in previous studies with BIIB080
Use of symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine, tacrine or 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 Day 1
Prior participation in any active or passive immunotherapy study targeting Aβ or tau, unless documentation of receipt of placebo is available
Contraindications to having a MRI brain scan (e.g., pacemaker, MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed))
Any vaccination given within 10 days prior to Day 1 (COVID-19 vaccinations are allowed during the study, as well as other types of immunisation/vaccination/booster, except during the 10 days before and after clinic visits)
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.

Key exclusion criteria for Long-Term Extension Period includes:

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.