Study on the Safety and Effects of 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 the effects of a treatment called BIIB080 for individuals with Mild Cognitive Impairment due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia. The treatment involves a special type of medication known as an antisense oligonucleotide, which is designed to target specific proteins in the brain that are associated with Alzheimer’s disease. The study also uses a medication called Vizamyl, which is a solution for injection that helps in imaging the brain, and Neuraceq, another imaging agent. A placebo, which is an inactive substance, is also used for comparison.

The purpose of the study is to learn about the safety of BIIB080 and whether it can improve symptoms in participants. Participants will receive the treatment through an injection into the spinal fluid, a method known as intrathecal use. The study will last for a period of 76 weeks, during which participants will be monitored for changes in their cognitive abilities and overall health. The study aims to understand how different doses of the treatment affect the symptoms of Alzheimer’s disease.

Throughout the study, participants will undergo various assessments to track their progress. These assessments include tests to measure memory and thinking skills, as well as monitoring for any side effects or adverse events. The study is designed to provide valuable information on the potential benefits and safety of BIIB080 for individuals with early stages 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.

The assessment involves a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test, which measures memory, and a Clinical Dementia Rating (CDR) test to assess cognitive function.

2 baseline visit

A baseline visit is scheduled to establish initial health and cognitive status. This visit includes a physical examination and collection of medical history.

During this visit, a lumbar puncture may be performed to collect cerebrospinal fluid for analysis.

3 treatment administration

Participants receive the study medication, BIIB080, or a placebo through intrathecal use, which means it is injected into the spinal canal.

The medication is administered at regular intervals as determined by the study protocol.

4 regular monitoring

Participants attend regular visits to monitor health and cognitive function. These visits include physical exams and cognitive tests.

Monitoring continues throughout the study to ensure safety and track any changes in symptoms.

5 imaging assessments

Participants undergo imaging assessments using flutemetamol (18F) or florbetaben (18F) through intravenous injection to evaluate brain changes.

These assessments help in understanding the effects of the treatment on brain structure and function.

6 final evaluation

At the end of the study period, a final evaluation is conducted to assess overall health and cognitive changes.

This includes repeating the initial assessments and comparing results to determine the treatment’s effectiveness.

Who Can Join the Study?

Must have a diagnosis of 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 lower, which shows memory problems.
Must have a Clinical Dementia Rating (CDR) global score of 0.5 for MCI or 0.5 or 1 for mild dementia.
Must have a Mini-Mental State Examination (MMSE) score between 21 and 30.
Must have a CDR Memory Box score of 0.5 or higher.
Must show evidence of amyloid pathology, which is a protein related to Alzheimer’s, through specific tests like PET scans or spinal fluid sampling.
Must be able to understand the study’s purpose and risks, and provide consent, either personally or through a legal representative.
Must have completed the initial part of the study, including the Week 76 visit.
Must have taken at least 5 doses of the study medication or placebo during the initial study period.
Must be medically able to undergo study procedures, including a lumbar puncture (a procedure to collect spinal fluid), and follow the visit schedule.
Must be in good health apart from Alzheimer’s Disease, as determined by the study doctor.
Must have a care partner who spends at least 10 hours per week with them and can provide information about their abilities.

Who Cannot Join the Study?

Patients with any other serious medical condition that might 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 with a history of severe allergic reactions to any medication.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have been diagnosed with a psychiatric disorder that is not stable.
Patients who have a history of seizures or epilepsy.
Patients who have uncontrolled high blood pressure.
Patients who have a history of heart disease or stroke.
Patients who have a history of cancer within the past five years, except for certain types of skin cancer.
Patients who have a history of liver or kidney disease.
Patients who have a history of HIV or other immune system disorders.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Novo-Med Zielinski I Wspolnicy Sp. j.	Katowice	Poland
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
Oroitu S.L.	Algorta	Spain
Forbeli s.r.o.	Prague	Czechia
University Hospital Ostrava	Ostrava	Czechia
Hopital Purpan	Toulouse	France
Centre Hospitalier Universitaire De Nantes	Saint-Herblain	France
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
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
Karolinska University Hospital	Solna	Sweden
Charite Universitatsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Aalborg University Hospital	Aalborg	Denmark
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Vestra Clinics s.r.o.	Rychnov Nad Kneznou	Czechia
Rigshospitalet	Copenhagen	Denmark
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
Care Clinic Sp. z o.o.	Katowice	Poland
Cuqjjhovc Utypqekqwfxixo Sxkxpssfq	Woluwe-Saint-Lambert	Belgium
Szbasvbwxgq Ulmynkpwqc Hziazjsbudvmgzi Gmaxawkfmkofbnxpm	Molndal	Sweden
Ugunixkyap Htijrmvn Ceovxhs	Cologne	Germany
Fochpsmc njrciqkue Midip a Hjopwmu	Prague	Czechia
Araouvjivm Pcokcyiu Hfcrjwyu Dh Phaki	Paris	France
Kyngbcxr Bsutgwsv Gcat	Bayreuth	Germany
Hqttjonn Dg Lm Subcv Chhe I Skqp Pda	Barcelona	Spain
Udsuzuavel Dtfmc Svgsz Dh Rjil Lz Sazvakee	Rome	Italy
Kaapzifb Amxbsxhtclt Lguo Gvta	Altenburg	Germany
Uitmvutjyx Hhonagpde Pnhgh Sdzwgcatzza Ctsywhg Fava	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.09.2023
Czechia	Not recruiting	11.09.2023
Denmark	Not recruiting	11.09.2023
Finland	Not recruiting	11.09.2023
France	Not recruiting	11.09.2023
Germany	Not recruiting	11.09.2023
Italy	Not recruiting	11.09.2023
Poland	Not recruiting	11.09.2023
Spain	Not recruiting	11.09.2023
Sweden	Not recruiting	11.09.2023
The Netherlands	Not recruiting	11.09.2023

Trial locations

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 trial aims to understand how effective and safe BIIB080 is for patients, and how well it is tolerated over time. Participants in the study will receive this medication to see if it can improve their cognitive function and overall quality of life 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 maintaining stable symptoms 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 cognitive impairment, where individuals require full-time care and assistance with daily living.

Trial ID:

2022-501644-15-01

Protocol code:

247AD201

NCT ID:

NCT05399888

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of BIIB080 for Patients Aged 50-80 with Mild Cognitive Impairment or Mild Alzheimer’s Disease Dementia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?