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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Charite Universitatsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire Rouen Rouen France
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
University Of Strasbourg STRASBOURG, Alsace France
Neuro Health Centrum s.r.o. Brno Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Karolinska University Hospital Solna Sweden
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Rigshospitalet Copenhagen Denmark
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
University Of Eastern Finland Kuopio Finland
Katholisches Klinikum Bochum gGmbH Bochum Germany
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Clinical Research Services Turku CRST Oy Turku Finland
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Hospital Universitari De Santa Maria Lleida Spain
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Revit Sp. z o.o. Bialystok Poland
Centrum Medyczne Senior Sopot Poland
Promente Sp. z o.o. Bydgoszcz Poland
Neuroprotect Sp. z o.o. Warsaw Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Hospices Civils de Lyon (HCL) – Hôpital des Charpennes Villeurbanne France
University Hospital Ostrava Ostrava Czechia
Hopital Purpan Toulouse France
Forbeli s.r.o. Prague Czechia
Care Clinic Sp. z o.o. Katowice Poland
Oroitu S.L. Algorta Spain
University Of Frankfurt Frankfurt Germany
Ktovilqg Bkwkelao Gstb Bayreuth Germany
Nbxdytqy Zgputavll I Wnklcvfjw Sel jj Katowice Poland
Ccqwptksh Ulsaonveefanbc Skddnblsh Woluwe-Saint-Lambert Belgium
Sashlcrbxnc Ufbxayubpp Hsnlllnplltlnbo Gojdchvdsrvicxost Molndal Sweden
Fuuhxegl nbjwlippr Mxqls a Hosrdkc Prague Czechia
Adjpeincaw Pvvzlcdb Hceonxia Ds Pbimi Paris France
Hsvbqzus Ds Lu Szoir Caej I Sqys Ppt Barcelona Spain
Udlgpzesup Dewja Sxplv De Rfey Lf Swzjwmrk Rome Italy
Kwnjruwy Awqaiqkdofk Ldrj Gipe Altenburg Germany
Uhmtqwxjek Hoervpbxn Pmsce Seenycppjmb Cwynmpl Figl Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
14.03.2023
Czechia Czechia
Not yet recruiting
14.03.2023
Denmark Denmark
Not yet recruiting
14.03.2023
Finland Finland
Not yet recruiting
14.03.2023
France France
Not yet recruiting
14.03.2023
Germany Germany
Not yet recruiting
14.03.2023
Italy Italy
Not yet recruiting
14.03.2023
Poland Poland
Not yet recruiting
14.03.2023
Spain Spain
Not yet recruiting
14.03.2023
Sweden Sweden
Not yet recruiting
14.03.2023
The Netherlands The Netherlands
Not yet recruiting
14.03.2023

Trial locations

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.

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 ID:
2022-501644-15-00
Protocol code:
247AD201
NCT ID:
NCT05399888
Trial Phase:
Therapeutic exploratory (Phase II)

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