Clinical trial NCT03352557: Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Mild cognitive impairment
Alzheimer's disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 654
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
measure: LTE Period: Percentage of Participants With AEs and SAEs
timeFrame: From Week 80 to Week 173
Secondary outcomes:
measure: PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 78
measure: PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
timeFrame: Baseline up to Week 76
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience Inc
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Carlsbad
country: United States
facility: The Research Center of Southern California
state: California
city: Fremont
country: United States
facility: Positron Research International
state: California
city: Fresno
country: United States
facility: Neuropain Medical Center
state: California
city: Hanford
country: United States
facility: V Royter, MD, APMC
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research, Inc.
state: California
city: Lancaster
country: United States
facility: Research Center for Clinical Studies West
state: California
city: Los Angeles
country: United States
facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: New Haven
country: United States
facility: Invicro
state: Connecticut
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc. - Orlando
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Atlanta
country: United States
facility: Emory University Cognitive Neurology Clinic & ADRC
state: Georgia
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Tufts
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital Department of Neurology
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S. Marks, M.D., P.C.
state: Massachusetts
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Springfield
country: United States
facility: The Cognitive Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Enhancement Center of NJ
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center PRIME
state: New York
city: Rochester
country: United States
facility: AD-CARE, University of Rochester
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, PC
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic, Inc.
state: Vermont
city: Fairfax
country: United States
facility: Cognition Health
state: Virginia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Caulfield
country: Australia
facility: Caulfield Hospital
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Strasbourg Cedex
country: France
facility: CHU Strasbourg - Hôpital Hautepierre
state: Bas Rhin
city: Bordeaux Cedex
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin
state: Gironde
city: Toulouse Cedex 9
country: France
facility: Hôpital La Grave
state: Haute Garonne
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
state: Herault
city: Rennes cedex 2
country: France
facility: CHU Rennes - Pontchaillou
state: Ille Et Vilaine
city: Nantes cedex 1
country: France
facility: CHU Nantes - Hopital Nord Laënnec
state: Loire Atlantique
city: Paris cedex 10
country: France
facility: Hôpital Lariboisière
state: Paris
city: Villeurbanne
country: France
facility: Hôpital des Chapennes
state: Rhone
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Böblingen
country: Germany
facility: Studienzentrum fur Neurologie und Psychiatrie
state: Baden Wuertemberg
city: Mannheim
country: Germany
facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit
state: Baden Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden Wuerttemberg
city: Muenchen
country: Germany
facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn AoeR
state: Nordrhein Westfalen
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
state: Thueringen
city: Berlin
country: Germany
facility: Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
city: Vicenza
country: Italy
facility: ULSS 6 Vicenza
city: Obu-shi
country: Japan
facility: Research Site
state: Aichi-Ken
city: Chiba-shi
country: Japan
facility: Research Site
state: Chiba-Ken
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa-Ken
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto-Fu
city: Kurashiki-shi
country: Japan
facility: Research Site
state: Okayama-Ken
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka-Fu
city: Bydgoszcz
country: Poland
facility: PALLMED Sp. z o.o.
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Sopot
country: Poland
facility: Centrum Medyczne Senior
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Warszawa
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
city: Getxo
country: Spain
facility: CAE Oroitu
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Fundacio ACE
city: Lleida
country: Spain
facility: Hospital de Santa Maria
city: Madrid
country: Spain
facility: Complejo Hospitalario Ruber Juan Bravo
city: Sevilla
country: Spain
facility: Hospital Victoria Eugenia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus
city: Molndal
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Huddinge
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: