Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
- Registration Number
- NCT03352557
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.
The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 654
- Must have a gradual and progressive change in memory function over more than 6 months.
- Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have
- Objective evidence of cognitive impairment at Screening
- Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD
- Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)
- CDR Memory Box score of ≥0.5
- Must consent to apolipoprotein E (ApoE) genotyping
- Must have 1 informant/study partner
- Must have amyloid beta positivity confirmed at Screening
Key
- Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
- Clinically significant, unstable psychiatric illness
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
- Indication of impaired renal or liver function
- Alcohol or substance abuse in past 1 year
- Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
- Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.
- Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
- Contraindications to study procedures
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose BIIB092 BIIB092 Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind. Medium-dose BIIB092 BIIB092 Intravenous (IV) infusion once every 4 weeks. High-dose BIIB092 BIIB092 Intravenous (IV) infusion once every 4 weeks. Placebo Placebo Intravenous (IV) infusion once every 4 weeks.
- Primary Outcome Measures
Name Time Method PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period) AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
LTE Period: Percentage of Participants With AEs and SAEs From Week 80 to Week 173 An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
- Secondary Outcome Measures
Name Time Method PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score Baseline, Week 78 The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum Baseline up to Week 76
Trial Locations
- Locations (95)
The Research Center of Southern California
🇺🇸Carlsbad, California, United States
Karolinska Universitetssjukhuset, Huddinge
🇸🇪Stockholm, Sweden
Ospedale San Raffaele
🇮🇹Milano, Italy
ULSS 6 Vicenza
🇮🇹Vicenza, Italy
CAE Oroitu
🇪🇸Getxo, Vizcaya, Spain
Research Site
🇯🇵Suita-shi, Osaka-Fu, Japan
Complejo Hospitalario Ruber Juan Bravo
🇪🇸Madrid, Spain
PALLMED Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Senior
🇵🇱Sopot, Poland
Klinikum Altenburger Land GmbH
🇩🇪Altenburg, Thueringen, Germany
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
🇮🇹Roma, Italy
The Memory Clinic, Inc.
🇺🇸Bennington, Vermont, United States
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
🇩🇪Berlin, Germany
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
IRCCS Centro San Giovanni di Dio Fatebenefratelli
🇮🇹Brescia, Italy
Fundacio ACE
🇪🇸Barcelona, Spain
The Cognitive Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Hospital de Santa Maria
🇪🇸Lleida, Spain
Azienda Ospedaliero Universitaria Policlinico Paolo
🇮🇹Palermo, Italy
AD-CARE, University of Rochester
🇺🇸Rochester, New York, United States
Skånes Universitetssjukhus
🇸🇪Malmo, Sweden
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
🇵🇱Lublin, Poland
Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
🇵🇱Warszawa, Poland
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hôpital La Grave
🇫🇷Toulouse Cedex 9, Haute Garonne, France
Xenoscience Inc
🇺🇸Phoenix, Arizona, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Dignity Health
🇺🇸Phoenix, Arizona, United States
Neuropain Medical Center
🇺🇸Fresno, California, United States
Irvine Center for Clinical Research, Inc.
🇺🇸Irvine, California, United States
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Emory University Cognitive Neurology Clinic & ADRC
🇺🇸Atlanta, Georgia, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Brigham and Women's Hospital Department of Neurology
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Cognition Health
🇺🇸Fairfax, Virginia, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, France
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Victoria Eugenia
🇪🇸Sevilla, Spain
Research Center for Clinical Studies West
🇺🇸Lancaster, California, United States
Positron Research International
🇺🇸Fremont, California, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
V Royter, MD, APMC
🇺🇸Hanford, California, United States
Stanford Hospital and Clinics
🇺🇸Palo Alto, California, United States
Brain Matters Research
🇺🇸Stuart, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Synexus Clinical Research US, Inc. - The Villages
🇺🇸The Villages, Florida, United States
Tufts
🇺🇸Boston, Massachusetts, United States
ActivMed Practices & Research
🇺🇸Methuen, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Donald S. Marks, M.D., P.C.
🇺🇸Plymouth, Massachusetts, United States
Advanced Memory Enhancement Center of NJ
🇺🇸Toms River, New Jersey, United States
New York University Medical Center PRIME
🇺🇸New York, New York, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States
Caulfield Hospital
🇦🇺Caulfield, Victoria, Australia
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
🇫🇷Bordeaux Cedex, Gironde, France
Austin Hospital
🇦🇺Heidelberg West, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
CHU Nantes - Hopital Nord Laënnec
🇫🇷Nantes cedex 1, Loire Atlantique, France
CHU Strasbourg - Hôpital Hautepierre
🇫🇷Strasbourg Cedex, Bas Rhin, France
Hôpital Lariboisière
🇫🇷Paris cedex 10, Paris, France
CHU Rennes - Pontchaillou
🇫🇷Rennes cedex 2, Ille Et Vilaine, France
Hopital Gui de Chauliac
🇫🇷Montpellier, Herault, France
Studienzentrum fur Neurologie und Psychiatrie
🇩🇪Böblingen, Baden Wuertemberg, Germany
Hôpital des Chapennes
🇫🇷Villeurbanne, Rhone, France
ISPG - Institut fuer Studien zur Psychischen Gesundheit
🇩🇪Mannheim, Baden Wuerttemberg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden Wuerttemberg, Germany
Institut fuer Schlaganfall- und Demenzforschung (ISD)
🇩🇪Muenchen, Bayern, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Hessen, Germany
Universitaetsklinikum Bonn AoeR
🇩🇪Bonn, Nordrhein Westfalen, Germany
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
🇸🇪Molndal, Sweden
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Invicro
🇺🇸New Haven, Connecticut, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Synexus Clinical Research US, Inc. - Orlando
🇺🇸Orlando, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States