Clinical trial NCT03518073: A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Official title: Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease (AD)
Keywords: Memory problems
Cognitive impairment
PERISCOPE-ALZ
Dementia
Tauopathy
Neurofibrillary tangles
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).


Eligibility criteria: Inclusion Criteria:

* Participants must have gradual and progressive change in memory function for \>6 months.
* Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.

Exclusion Criteria:

* Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.
* Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \<24 months.
* Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.
* Participants must not have serious risk for suicide.
* Participants must not have history of drug or alcohol use disorder within the last 2 years.
* Participants must not have multiple severe drug allergies
* Participants must not have HIV, Hepatitis B or Hepatitis C
* Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy

Primary outcomes:
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, Week 104
Secondary outcomes:
measure: Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Mini Mental Status Examination (MMSE) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan.
timeFrame: Baseline, Week 104
measure: Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
timeFrame: Baseline, Week 104
measure: Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline through Week 104
measure: Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab
timeFrame: Baseline through Week 113
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Panorama City
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Francisco
country: United States
facility: Univ of California San Francisco
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Julie B. Schwartzbard, MD, PA
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories Clinical Research
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: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: VIN-Victor Faradji
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: BioClinica Inc
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: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center, PC
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Elk Grove Village
country: United States
facility: AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: University of Cincinnati Health Neurology
state: Ohio
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Baylor AT&T Memory Center
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Ins
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Fairfax
country: United States
facility: Cognition Health
state: Virginia
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ca-on
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Gatineau
country: Canada
facility: Clinique de la Mémoire de l'Outaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: NeuroSearch Developements
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc.
state: Quebec
city: Obu City
country: Japan
facility: National Center for Geriatrics and Gerontology
state: Aichi
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
state: Jp-13
city: Kyoto
country: Japan
facility: National hospital Organization Utano National Hospital
state: Jp-26
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Jp-33
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: