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

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ClinicalTrials.gov Identifier: NCT02783573
Recruitment Status : Terminated (An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.)
First Posted : May 26, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Lanabecestat Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5697 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose 1 of Lanabecestat
Dose 1 of lanabecestat given orally once daily for 156 weeks.
 Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293
Experimental: Dose 2 of Lanabecestat
Dose 2 of lanabecestat given orally once daily for 156 weeks.
 Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293
Experimental: Placebo (Dose 1 of Lanabecestat)
Placebo given orally once daily for 78 weeks and then dose 1 of lanabecestat given orally once daily until week 156.
 Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Drug: Placebo
Administered orally
Experimental: Placebo (Dose 2 of Lanabecestat)
Placebo given orally once daily for 78 weeks and then dose 2 of lanabecestat given orally once daily until week 156.
 Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score [ Time Frame: Baseline, Week 78 ]

Secondary Outcome Measures :
  1. Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score [ Time Frame: Baseline, Week 78 ]
  2. Change from Baseline in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 78 ]
  3. Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 78 ]
  4. Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 78 ]
  5. Change in Clinical Dementia Rating (CDR) Global Score [ Time Frame: From Loss of 1 Global Stage through Week 78 ]
  6. Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 78 ]
  7. Change from Baseline on the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 78 ]
  8. Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 78 ]
  9. Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 78 ]
  10. Change from Baseline in CSF Biomarker Total Tau [ Time Frame: Baseline, Week 78 ]
  11. Change from Baseline in CSF Biomarker Phosphorylated Tau [ Time Frame: Baseline, Week 78 ]
  12. Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan [ Time Frame: Baseline, Week 78 ]
  13. Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan [ Time Frame: Baseline, Week 78 ]
  14. Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 78 ]
  15. Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat [ Time Frame: Predose Week 4 through Week 71 ]
  16. Population PK: Central Volume of Distribution of Lanabecestat [ Time Frame: Predose Week 4 through Week 71 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783573


  Show 262 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
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Additional Information:
Click here for more information about this study: A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02783573     History of Changes
Other Study ID Numbers: 16024
I8D-MC-AZET ( Other Identifier: Eli Lilly and Company )
2015-005625-39 ( EudraCT Number )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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