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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 : Recruiting
First Posted : May 26, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

May 24, 2016
May 26, 2016
January 9, 2018
July 2016
September 2019   (Final data collection date for primary outcome measure)
Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score [ Time Frame: Baseline, Week 78 ]
Same as current
Complete list of historical versions of study NCT02783573 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 78 ]
  • Change in Clinical Dementia Rating (CDR) Global Score [ Time Frame: From Loss of 1 Global Stage through Week 78 ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline on the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in CSF Biomarker Total Tau [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in CSF Biomarker Phosphorylated Tau [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 78 ]
  • Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat [ Time Frame: Predose Week 4 through Week 71 ]
  • Population PK: Central Volume of Distribution of Lanabecestat [ Time Frame: Predose Week 4 through Week 71 ]
  • Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 78 ]
  • Change in Clinical Dementia Rating (CDR) Global Score [ Time Frame: From Loss of 1 Global Stage through Week 78 ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline on the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in CSF Biomarker Total Tau [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in CSF Biomarker Phosphorylated Tau [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan [ Time Frame: Baseline, Week 78 ]
  • Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 78 ]
  • Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814 [ Time Frame: Predose Week 4 through Week 71 ]
  • Population PK: Central Volume of Distribution of LY3314814 [ Time Frame: Predose Week 4 through Week 71 ]
Not Provided
Not Provided
 
A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Lanabecestat
    Administered orally
    Other Names:
    • LY3314814
    • AZD3293
  • Drug: Placebo
    Administered orally
  • Experimental: Dose 1 of Lanabecestat
    Dose 1 of lanabecestat given orally once daily for 156 weeks.
    Intervention: Drug: Lanabecestat
  • Experimental: Dose 2 of Lanabecestat
    Dose 2 of lanabecestat given orally once daily for 156 weeks.
    Intervention: Drug: Lanabecestat
  • 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.
    Interventions:
    • Drug: Lanabecestat
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Lanabecestat
    • Drug: Placebo
Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjäll S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1899
March 2021
September 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Senior)
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Belgium,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT02783573
16024
I8D-MC-AZET ( Other Identifier: Eli Lilly and Company )
2015-005625-39 ( EudraCT Number )
Yes
Not Provided
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.
Eli Lilly and Company
Eli Lilly and Company
AstraZeneca
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
Eli Lilly and Company
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP