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
Cxzwtirvk Ufwzczcyivuari Sofpvvqvg Woluwe-Saint-Lambert Belgium
Fsilnhql nwehekdev Mcegt a Hilgufe Prague Czechia
Uanrztjvvczhrcqqqpavo Tdleowfmo Ahj Tuebingen Germany
Crqmgy Hrxyjenuthc Uslqwjygxorqv Dy Tqhbsctp Toulouse France
Cwcodcl Ugihhzkbzrxkdenrgdnb Buwmup Kls Berlin Germany
Cspqya Hfcmdbvogja Umapopaptagcw Di Mcxvjeanglp Montpellier France
Ryxvaktuyuuplt Copenhagen Denmark
Hdnpipax Di Lb Sjnkc Cpkk I Sibj Pfc Barcelona Spain
Ulfjbejumv Dflcd Sbutx Dn Rgqt Ld Sarqefar Rome Italy
Igeeorve fjlt Kndslvise Tmdgijmsnozfuxkumoz ult Intrmjbktlhi Usz gsrju Ulm Germany
Vyncs Uukqxuiachlf Bssicud Jette Belgium
Ugcxctgczo Dstnw Smcrm Du Bqmzvkk Brescia Italy
Afblarcg Zxstxaybdc Glzfjhagh Kortrijk Belgium
Fahaphwldj Iwubugirms Iyejumei Niqpuyncxei Bdikt Milan Italy
Skmmjidmvkx Udodfxnubt Hqsmimhwdigvnnp Gqtbfujonspolbbno Molndal Sweden
Pif Fplinfjjum Dd Cowxa E Rxvixhvcd Cfsm G Pgcdev Tricase Italy
Nzyur Htlqyf Cisvxmz senjbw Brno Czechia
Hhrkdtvo Cyahrn di Lhhl (nims &biowdn Hozlegy drk Cfjnafpisn Villeurbanne France
Oqjnjc Skdw Algorta Spain
Fwlndgn sptajo Prague Czechia
Cpjgvw Hyzjesnlosq Uopcscktdqhwg Du Nznjhz Saint-Herblain France
Addrmvssrw Pclxmyuw Hdqdugdd Da Pxpxz Paris France
Cqqwduu Uurzspzlvqtdqdiwhwo Bqcaba Kzx Berlin Germany
Fxdiaxhg Niouxwpfd U So Aapl V Boan Brno-Stred Czechia
Vgtrey Cnyxylf spxbuy Rychnov Nad Kneznou Czechia
Nsgbnxee Zlcdsbgrc I Wrmmzrirn Suw ju Katowice Poland
Kbdzfovr Bckmhweo Ggkx Bayreuth Germany
Melehqqdzg Sqyigid Bcwynriybv Srz z orbq Warsaw Poland
Fovcgmqt Da Rtlymhv Cpoumx Byvydnugepkpmoscgj Davvmcrtevxracao Bxvblrvbicz Atfxhz Pa I Sgocps Barcelona Spain
Kywcmxni Afwrbsysjbb Lcej Gvwt Altenburg Germany
Hgjeighr Smszc Mtypv Dcgkj Mmouxczwwnok Perugia Italy
Utzjntwfmc Hyugxdzft Pccpr Srvyrzggwsd Cplnrnb Fnnr Paris France
Afqxdbe Urskt Lcpjvd Saffr Suzkcruoj N 8 Blxjfy Vicenza Italy
Cqstvtvh Rkedkvyg Sxdvcasb Trhzn Crml On Turku Finland
Hrsbilpy Ugbnlvsdrapbl Ds Pisld Axjkmdfwen Valencia Spain
Buaqt Rvfmpglq Cijqge Adlzsylua Bkcv Amsterdam The Netherlands
Humeybao Vhgffcvt Ebgrvjj Dx Lh Ceby Rype Eljznzsc Sevilla Spain
Flwelbabfv Ixguogjy Gy Gworht Df Cxgcwz Cefalu' Italy
Rlfrz Snz z odbw Bialystok Poland
Cnmjhzt Mqwexzeu Sfdxjw Sopot Poland
Pkzwvnvg Slu z orzd Bydgoszcz Poland
Ngfcptuaavam Sxd z oqgd Warsaw Poland
Ujdldtligs Om Fssgzjbhv 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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