Trial record 11 of 29 for:    neurology AND University AND San Francisco | Open Studies | Exclude Unknown

A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Eli Lilly and Company
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02783573
First received: May 24, 2016
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
The main purpose of this study is to evaluate the efficacy of the study drug known as LY3314814 in participants with mild Alzheimer's disease (AD) dementia.

Condition Intervention Phase
Alzheimer's Disease
Drug: LY3314814
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating (CDR) Global Score [ Time Frame: From Loss of 1 Global Stage through Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline on the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in CSF Biomarker Total Tau [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in CSF Biomarker Phosphorylated Tau [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 78 ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814 [ Time Frame: Predose Week 4 through Week 71 ] [ Designated as safety issue: No ]
  • Population PK: Central Volume of Distribution of LY3314814 [ Time Frame: Predose Week 4 through Week 71 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1899
Study Start Date: June 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 of LY3314814
Dose 1 of LY3314814 given orally once daily for 156 weeks.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Experimental: Dose 2 of LY3314814
Dose 2 of LY3314814 given orally once daily for 156 weeks.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Experimental: Placebo (Dose 1 of LY3314814)
Placebo given orally once daily for 78 weeks and then dose 1 of LY3314814 given orally once daily until week 156.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Drug: Placebo
Administered orally
Experimental: Placebo (Dose 2 of LY3314814)
Placebo given orally once daily for 78 weeks and then dose 2 of LY3314814 given orally once daily until week 156.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
  • MMSE score of 20 to 26 inclusive at screening visit.
  • For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
  • Evidence of amyloid pathology.
  • The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

Exclusion Criteria:

  • Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
  • Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
  • Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
  • Congenital QT prolongation.
  • Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
  • A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
  • History of malignant cancer within the last 5 years.
  • History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
  • Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
  • Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02783573

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 134 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02783573     History of Changes
Other Study ID Numbers: 16024  I8D-MC-AZET  2015-005625-39 
Study First Received: May 24, 2016
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Ministry of Health and Welfare
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Keywords provided by Eli Lilly and Company:
dementia
brain diseases
neurodegenerative diseases
central nervous system diseases
nervous system diseases
mental disorders
delirium, dementia, amnestic, cognitive
tauopathies
memory
amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2016