Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— TANGO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03352557
• Other study ID #: 251AD201
• Secondary ID: 2017-002901-37
• Status: Terminated
• Phase: Phase 2
• Start date: May 3, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2022
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 654
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• BIIB092
Administered as specified in treatment arm.
• Placebo
Administered as specified in treatment arm.

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Caulfield Hospital	Caulfield	Victoria
Australia	Austin Hospital	Heidelberg West	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
France	Groupe Hospitalier Pellegrin - Hôpital Pellegrin	Bordeaux Cedex	Gironde
France	Hopital Gui de Chauliac	Montpellier	Herault
France	CHU Nantes - Hopital Nord Laënnec	Nantes cedex 1	Loire Atlantique
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hôpital Lariboisière	Paris cedex 10	Paris
France	CHU Rennes - Pontchaillou	Rennes cedex 2	Ille Et Vilaine
France	CHU Strasbourg - Hôpital Hautepierre	Strasbourg Cedex	Bas Rhin
France	Hôpital La Grave	Toulouse Cedex 9	Haute Garonne
France	Hôpital des Chapennes	Villeurbanne	Rhone
Germany	Klinikum Altenburger Land GmbH	Altenburg	Thueringen
Germany	Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)	Berlin
Germany	Studienzentrum fur Neurologie und Psychiatrie	Böblingen	Baden Wuertemberg
Germany	Universitaetsklinikum Bonn AoeR	Bonn	Nordrhein Westfalen
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Hessen
Germany	ISPG - Institut fuer Studien zur Psychischen Gesundheit	Mannheim	Baden Wuerttemberg
Germany	Institut fuer Schlaganfall- und Demenzforschung (ISD)	Muenchen	Bayern
Germany	Universitaetsklinikum Ulm	Ulm	Baden Wuerttemberg
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo	Palermo
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza	Roma
Italy	ULSS 6 Vicenza	Vicenza
Japan	Research Site	Chiba-shi	Chiba-Ken
Japan	Research Site	Kawasaki-shi	Kanagawa-Ken
Japan	Research Site	Kurashiki-shi	Okayama-Ken
Japan	Research Site	Kyoto-shi	Kyoto-Fu
Japan	Research Site	Obu-shi	Aichi-Ken
Japan	Research Site	Suita-shi	Osaka-Fu
Poland	PALLMED Sp. z o.o.	Bydgoszcz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie	Lublin
Poland	Centrum Medyczne Senior	Sopot
Poland	Centrum Medyczne NeuroProtect	Warszawa
Poland	Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo	Warszawa
Spain	Fundacio ACE	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	CAE Oroitu	Getxo	Vizcaya
Spain	Hospital de Santa Maria	Lleida
Spain	Complejo Hospitalario Ruber Juan Bravo	Madrid
Spain	Hospital Victoria Eugenia	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Sweden	Skånes Universitetssjukhus	Malmo
Sweden	Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus	Molndal
Sweden	Karolinska Universitetssjukhuset, Huddinge	Stockholm
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Emory University Cognitive Neurology Clinic & ADRC	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	McLean Hospital	Belmont	Massachusetts
United States	The Memory Clinic, Inc.	Bennington	Vermont
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital Department of Neurology	Boston	Massachusetts
United States	Tufts	Boston	Massachusetts
United States	The Research Center of Southern California	Carlsbad	California
United States	Cleveland Clinic	Cleveland	Ohio
United States	Neurology Clinic, PC	Cordova	Tennessee
United States	Brain Matters Research	Delray Beach	Florida
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Cognition Health	Fairfax	Virginia
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Positron Research International	Fremont	California
United States	Neuropain Medical Center	Fresno	California
United States	V Royter, MD, APMC	Hanford	California
United States	Baylor College of Medicine	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Irvine Center for Clinical Research, Inc.	Irvine	California
United States	Research Center for Clinical Studies West	Lancaster	California
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Mary S. Easton Center for Alzheimer's Disease Research, UCLA	Los Angeles	California
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Invicro	New Haven	Connecticut
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	New York University Medical Center PRIME	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Boston Center for Memory	Newton	Massachusetts
United States	Renstar Medical Research	Ocala	Florida
United States	Synexus Clinical Research US, Inc. - Orlando	Orlando	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Dignity Health	Phoenix	Arizona
United States	Xenoscience Inc	Phoenix	Arizona
United States	Donald S. Marks, M.D., P.C.	Plymouth	Massachusetts
United States	Progressive Medical Research	Port Orange	Florida
United States	Butler Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	AD-CARE, University of Rochester	Rochester	New York
United States	Pacific Research Network, Inc	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	The Cognitive Research Center of New Jersey	Springfield	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Brain Matters Research	Stuart	Florida
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Synexus Clinical Research US, Inc. - The Villages	The Villages	Florida
United States	Advanced Memory Enhancement Center of NJ	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Japan,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
Primary	LTE Period: Percentage of Participants With AEs and SAEs	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.	From Week 80 to Week 173
Secondary	PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score	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).	Baseline, Week 78
Secondary	PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum		Baseline up to Week 76