Clinical trial NCT02791191: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
Official title: Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: BACE inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 316
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.


Eligibility criteria: Inclusion Criteria:

* Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
* Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
* Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

Exclusion Criteria:

* Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
* Use of strong inducers of cytochrome P450 3A (CYP3A).
* Sensitivity to florbetapir or ¹⁸F-AV-1451.
* Contraindication to MRI or PET or poor venous access for blood draws.

Primary outcomes:
measure: Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
timeFrame: Week 52
measure: Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
timeFrame: Week 52
measure: Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
timeFrame: Baseline through Week 52
measure: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
timeFrame: Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
measure: Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
timeFrame: Baseline, Week 52
measure: Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
timeFrame: Baseline, Week 52
measure: Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
timeFrame: Baseline, Week 52
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Irvine Clinical Research Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group
state: California
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Francisco
country: United States
facility: Ray Dolby Brain Health Center/Sutter Health/CPMC
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sebastopol
country: United States
facility: North Bay Neuroscience Institute
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Wilmington
country: United States
facility: Christiana Care Health Service
state: Delaware
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Melbourne
country: United States
facility: Compass Research
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: The Neurology Research Group, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Spring Hill
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Axiom Research
state: Florida
city: Gainesville
country: United States
facility: United Osteoporosis Center
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Bolivar
country: United States
facility: Missouri Memory Center
state: Missouri
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Creve Coeur
country: United States
facility: Millenium Psychiatric Associates LLC
state: Missouri
city: Kansas City
country: United States
facility: St Lukes Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Monroe
country: United States
facility: Pyramid Clinical Research
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Amherst
country: United States
facility: Dent Neurological Institute
state: New York
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Dayton
country: United States
facility: University of Cincinnati Health Neurology
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Shaker Heights
country: United States
facility: Insight Clinical Trials
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Jenkintown
country: United States
facility: Clinical Trial Center, LLC, Psychiatry
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor AT&T Memory Center
state: Texas
city: Houston
country: United States
facility: Nantz National Alzheimer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Services Center - Houston
state: Texas
city: Box Hill
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Chermside
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Darlinghurst
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Erina
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Glen Iris
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Heidelberg
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Herston
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nedlands
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Parkville
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: West Perth
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gatineau
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ottawa
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Verdun
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Akashi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hachioji
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ikeda
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kasukabe-shi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kyoto
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nagoya
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nerima-ku
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Osaka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Osaka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Setagaya-ku
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Takamatsu
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wako
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Yokosuka-shi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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: