A randomized study to assess the efficacy, safety, and tolerability of BIIB080 in patients with mild cognitive impairment due to Alzheimer's disease or mild dementia in Alzheimer's patients
Descrizione riassuntiva dello studio
This is a randomized, double-blind, placebo-controlled Phase II study that includes a double-blind, placebo-controlled treatment period and a follow-up period. Approximately 735 participants will be selected to receive one of 4 possible treatments for about 72 weeks. Selection is done via an interactive response system that determines your disease stage. This response system (Interactive Response Technology, IRT) is also used to ensure that during the later random allocation of patients, approximately equal numbers of participants with Alzheimer's disease (AD)-related mild cognitive impairment (MCI) or mild Alzheimer's dementia are included. Furthermore, it will be ensured that approximately 10% of the total participants included in the study are younger than 60 years. Neither your study doctor nor you will know whether you are receiving the drug BIIB080 or an inactive control drug (placebo) during the treatment. This is called “double-blind” and is intended to ensure that later evaluations are free from any influencing prior knowledge.
(BASEC)
Intervento studiato
This study investigates the following treatments:
60 mg Q24W (treatment once every 24 weeks with a dose of 60 mg of BIIB080)
115 mg Q24W (treatment once every 24 weeks with a dose of 115 mg of BIIB080)
115 mg Q12W (treatment once every 12 weeks with a dose of 115 mg of BIIB080)
Placebo Q12W (treatment once every 12 weeks with control substance, without BIIB080)
The drug or control substance is administered intrathecally, meaning it is injected directly into the cerebrospinal fluid (CSF) in the lumbar region via a lumbar puncture.
During the study, up to 12 outpatient visits (3 visits during the screening period, 8 visits during the placebo-controlled treatment period, and 1 visit during the follow-up period) and 14 follow-up phone calls will occur.
All outpatient visits should be conducted ± 7 days around the visit date. Follow-up phone calls occur approximately 48 hours after each dose, approximately 6 weeks after each dose, and once during the follow-up period.
To improve recruitment efficiency, a visit conducted by phone or by a local care service may occur prior to screening to allow for the pre-identification of participants who are most likely to meet the study's inclusion criteria.
(BASEC)
Malattie studiate
This study investigates the effect of BIIB080 on mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia. Beta-amyloid-containing extracellular plaques are a well-known hallmark of Alzheimer's disease. Pathological tau protein, which aggregates into abnormal bundles, is another hallmark of Alzheimer's disease. The “tau pathology” is directly related to the loss of brain cells and cognitive abilities. Previous non-clinical studies with so-called antisense oligonucleotides (ASOs) have shown that specifically designed ASOs can reverse tau deposition and loss of cognitive abilities. ASOs are short-chain, synthetically produced nucleic acids that, in the case of the study drug BIIB0880, block the formation of tau protein.
(BASEC)
You may participate in the study if, among other things, the following inclusion criteria apply to you: 1. Personal criteria: -You are able to understand the purpose and risks of the study and provide informed consent to participate in the study and to use confidential health data. -You are between 50 to 80 years old at the time of informed consent -You are willing to use a highly effective method of contraception during the study and for 52 weeks after the last dose of study treatment 2. Clinical criteria: -You have been diagnosed with amyloid pathology, measured by PET or cerebrospinal fluid samples -You meet all clinical criteria for “mild cognitive impairment” (MCI) due to Alzheimer’s or mild Alzheimer’s dementia. -You are willing to consent to apolipoprotein E (ApoE) genotyping. 3. You have a caregiver who: -is willing to accompany the participant to clinic visits and/or be available by phone at certain times to provide information to the investigator and study staff -fills out questions in prepared questionnaires during these clinic visits, -is willing to monitor the participant's intake of prescribed medications, -is available for the duration of the study, -is literate and can provide informed consent. (BASEC)
Criteri di esclusione
You cannot participate in the study if one or more of the following exclusion criteria apply to you: 1. Medical history and current health status: -Clinically significant cardiac, endocrinological, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other serious diseases in the past medical history -Infection with HIV, hepatitis B, hepatitis C, COVID-19, or symptoms of a bacterial, fungal, or viral infection within 14 days prior to screening -Any medical or neurological/neurodegenerative disease (other than Alzheimer’s) that, in the investigator's opinion, could be a cause of the participant's cognitive impairment -History of a serious infectious disease affecting the brain within 5 years prior to screening -Recently performed or soon-to-be-planned major surgical procedures -History of severe allergic or anaphylactic reactions, or a known allergy to BIIB080 or any of the components of the drug -Alcohol or drug abuse in the past medical history, a positive urine or alcohol test at screening, or the use of cannabinoids (including prescription) 2. Medication: -Previous participation in this study or previous studies with BIIB080 -Use of the following medications: • Benzodiazepines, antihistamines, anticonvulsants, antidepressants, anticholinergics • Previous use of levodopa or anti-Parkinson's medications, including dopaminergic agents, amantadine, selegiline, benztropine, and MAO inhibitors • Use of opioid medications within 4 weeks prior to the first visit. 3. Study procedures -Intolerance to MRI, PET scan (for participants agreeing to a PET scan), or lumbar puncture -A negative result of an amyloid PET scan within 6 months prior to screening -Female participants who are pregnant or currently breastfeeding or planning to become pregnant -Participants living in an organized care facility where extensive measures and/or support for activities of daily living are required (e.g., in a nursing home) (BASEC)
Luogo dello studio
Ginevra, Lugano, San Gallo, Altro
(BASEC)
Biel
(BASEC)
Sponsor
Biogen Idec Research Limited, UK Biogen Switzerland AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Leonardo Sacco
+41 91 8116111
leonardo.sacco@cluttereoc.chNeurocentro della Svizzera Italiana, Ospedale Regionale di Lugano
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
27.04.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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