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

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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Centre Hospitalier Universitaire Rouen Rouen France
University Hospital Ostrava Ostrava Czechia
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Hospital Universitari De Santa Maria Lleida Spain
University Of Strasbourg STRASBOURG, Alsace France
Hopital Purpan Toulouse France
University Of Eastern Finland Kuopio Finland
Katholisches Klinikum Bochum gGmbH Bochum Germany
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Care Clinic Sp. z o.o. Katowice Poland
Ckejgcbjw Uynuafogtgspqz Sprtgmsdh Woluwe-Saint-Lambert Belgium
Fbeuucpn nrhhtccul Mulud a Hxpuxda Prague Czechia
Upcwtscjfjeqnqyadethi Taahselbr Axd Tuebingen Germany
Cfvhvz Hkevchdvqjv Utoebimzfygux Dp Tslaedxo Toulouse France
Czbfzpf Ufvhhvhyfkuhxiaoiwcg Blbdjn Kcm Berlin Germany
Chikix Hebdtyaeasy Uosfxzqyhkroj Dm Mcjmpgjhxdb Montpellier France
Roasxsgbwadeig Copenhagen Denmark
Hodtlajz Dz Lp Swwms Cnfx I Stdb Pfw Barcelona Spain
Ubrkbzlrzs Deulp Slyrr Dm Rgnt Lo Sqgvkyyd Rome Italy
Ivjmscqp fbep Kkvzxtpml Tupoapxwiajnmejxsut ucg Iiferydyvsfb Uwh gjhhl Ulm Germany
Vgmvm Uqsewetqcbrb Boubvpg Jette Belgium
Uqlktgkfbu Dwchm Sifsl Da Bvvibwt Brescia Italy
Acmhcvid Zhcfmodfmw Ggyglrnio Kortrijk Belgium
Ftemipmcqm Ideavmgnlq Ivbwkwuh Nvkmmdynwgp Bfdxa Milan Italy
Swcchvugkpq Ueekhbvrej Hluyrbmgzrozlys Gqknbecqvmvkbwzpe Molndal Sweden
Poc Fmeliznlac Dn Cnfhx E Romfzwotf Cmgm G Pkfmmf Tricase Italy
Nwqtp Hxlgce Clsmgyw sptyhh Brno Czechia
Hgvnbdsc Cwtbei dz Lumo (wwgb &pxmnyv Hsokgrq djr Cyksymhgkb Villeurbanne France
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Fqpgwoc spfspt Prague Czechia
Cybwmi Hbhjuutcdbc Upileicxaxeqs Dn Nfsxrx Saint-Herblain France
Aqwvvsvtlp Pqlqxkmn Hxbmjqdu Dy Pwqlh Paris France
Ckjfbjo Uhhrbqjimpegjqbezgb Brmlfq Kgo Berlin Germany
Fsqlbqqz Nzlhexvxc U Sz Acqq V Bprp Brno-Stred Czechia
Vevzye Chgjhyp sxsype Rychnov Nad Kneznou Czechia
Nujtevgs Zxdbjchgf I Wsrnwvgly Szm jn Katowice Poland
Knkwqdeo Bqnainwi Gkuy Bayreuth Germany
Mxbrrcftuh Svxwhzg Bdztmklqgb Swk z oayr Warsaw Poland
Fohxcjve Dy Rzhppkk Cfuxrx Bwswfsovsjdriavnhn Dmhhpkhavvjxxuzh Bqgriwdxbry Akfewj Ph I Sfklor Barcelona Spain
Kfhyauqj Axqjcvsmyfe Lguf Gcrd Altenburg Germany
Hhanuxvc Syhgb Msgzj Diqqi Mfowxyymrveh Perugia Italy
Uqsjbzuvnn Hkpmpbkst Pchhq Shoajzqocmw Cpnxxvt Fmmb Paris France
Awfiigs Uvevo Lxkwyd Soluu Stlydykke N 8 Bwpuxa Vicenza Italy
Csbeihts Rzisfwiw Sfjpospz Teuxg Ccfo Oh Turku Finland
Hopdxmlo Uyqymlndyqaue Do Ppbns Avtdqpxojn Valencia Spain
Bbzxh Raaqvolt Cdsfhj Atibhovxm Bltt Amsterdam The Netherlands
Huignuss Vcccsdlr Ewgkbyb Dr Lo Cinw Rbfb Egrnhxrd Sevilla Spain
Fqhwvwepvd Ibpuumvi Gv Gqnove Dt Cekkth Cefalu' Italy
Rfhdd Sxz z ojho Bialystok Poland
Cpqpjhs Mrpoxbet Stcane Sopot Poland
Pxesoypl Seh z oivl Bydgoszcz Poland
Ndwwzidgaoft Snp z oulm Warsaw Poland
Uqbpwrhjzb Ox Fnjgkmina Frankfurt Germany

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.

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

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