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Study on BIIB080 for Patients Aged 50-80 with Mild Cognitive Impairment or Mild Alzheimer's Disease Dementia

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for individuals with Alzheimer's Disease, specifically those experiencing mild cognitive impairment or mild dementia due to Alzheimer's. The study involves a medication called BIIB080, which is an antisense oligonucleotide. This is a type of treatment designed to target and reduce the production of certain proteins associated with Alzheimer's Disease. The trial will also use a placebo for comparison purposes.

The purpose of the study is to assess the effectiveness, safety, and tolerability of BIIB080 when injected into the cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord. Participants will receive either the medication or a placebo over a period of time, and their progress will be monitored to see if there are any changes in their condition. The study will last for approximately 76 weeks, during which participants will undergo regular assessments to track any changes in their cognitive abilities and overall health.

Throughout the study, participants will be closely monitored for any side effects or adverse reactions to the treatment. The goal is to determine if BIIB080 can effectively alter the progression of Alzheimer's Disease and improve the quality of life for those affected by this condition. This research is important for developing new treatments that could potentially slow down or improve symptoms of Alzheimer's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating memory and cognitive abilities using specific tests.

    A positive result for amyloid pathology is required, which may involve a PET scan or cerebrospinal fluid sampling.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication BIIB080 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The study medication BIIB080 or placebo is administered through an injection into the cerebrospinal fluid. This is known as intrathecal use.

    The treatment is given at regular intervals as specified by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effects of the treatment. This includes cognitive assessments and checking for any side effects.

    The primary goal is to observe changes in cognitive function over time, specifically from the start of the study to week 76.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to assess the overall impact of the treatment on cognitive abilities.

    The results are compared to the initial assessment to determine any changes in cognitive function.

Who can join the trial?

9 criteria

  • Must have a condition called Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild Alzheimer's Disease dementia.
  • Must have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index score of 85 or less, which shows memory problems.
  • Must have a Clinical Dementia Rating (CDR) global score of 0.5 for MCI due to Alzheimer's or 0.5 or 1 for mild Alzheimer's dementia. This is a way to measure the severity of dementia.
  • Must have a Mini-Mental State Examination (MMSE) score between 22 and 30. This is a test that checks mental functions.
  • Must have a CDR Memory Box score of 0.5 or higher. This is another way to measure memory problems.
  • Must show evidence of amyloid pathology, which is a sign of Alzheimer's, through a positive test using either a brain scan called PET or a sample of cerebrospinal fluid (CSF).
  • Must be within the age range of 18 to 64 years old.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are included, meaning those who might need special protection or consideration.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could interfere with the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of severe allergic reactions.
  • Patients who are unable to comply with the study procedures.
  • Patients who have a significant psychiatric disorder that is not well controlled.
  • Patients who have a history of cancer within the past five years, except for certain types of skin cancer.
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Investigated drugs

BIIB080 is a medication being studied for its potential to help people with mild cognitive impairment or mild dementia due to Alzheimer's disease. This medication is designed to target and possibly slow down the progression of symptoms associated with Alzheimer's disease. The goal of the trial is to see how effective and safe BIIB080 is for patients, and to understand how it affects their cognitive abilities over time. Participants in the trial will receive this medication to see if it can help improve or stabilize their condition compared to those who do not receive it.

What is already known about the treatment

BIIB080 – BIIB080 is administered as an injection and is currently being studied in clinical trials for its potential to treat mild cognitive impairment and mild dementia due to Alzheimer's disease. This medication is still under investigation, and its effectiveness and safety are being evaluated in medical research. The main goal of BIIB080 is to slow down the progression of cognitive decline associated with Alzheimer's disease. It works by targeting specific proteins in the brain that are believed to contribute to the disease's development. BIIB080 is classified as an investigational drug, meaning it is not yet approved for general medical use.

Investigated diseases

  • Mild Cognitive Impairment due to Alzheimer's Disease

    This condition is characterized by a noticeable decline in cognitive abilities, such as memory and thinking skills, which is greater than expected for a person's age but does not interfere significantly with daily life. It is considered an early stage of Alzheimer's Disease, where individuals may experience forgetfulness, difficulty in finding words, or trouble with complex tasks. Over time, these cognitive changes may become more pronounced, potentially leading to more severe memory loss and confusion. The progression can vary, with some individuals remaining stable for years, while others may progress to Alzheimer's Disease Dementia.

  • Alzheimer's Disease Dementia

    This is a progressive neurological disorder that leads to the degeneration of brain cells, resulting in memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, gradually worsening to affect language, reasoning, and the ability to perform everyday activities. As the disease advances, individuals may experience significant memory loss, disorientation, and changes in behavior and personality. The progression of Alzheimer's Disease Dementia can lead to severe impairment in cognitive and functional abilities, requiring comprehensive care and support.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501644-15-00Protocol code247AD201Estimated enrolment735 patientsSponsorBiogen Idec Research Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).