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A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)
This study is currently recruiting participants.
Verified August 2017 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02783573
First received: May 24, 2016
Last updated: August 2, 2017
Last verified: August 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: Lanabecestat Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
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 ]
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 ]
- 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 ]
| Estimated Enrollment: | 1899 |
| Study Start Date: | July 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 Lanabecestat
Dose 1 of lanabecestat given orally once daily for 156 weeks.
|
Drug: Lanabecestat
Administered orally
Other Names:
|
|
Experimental: Dose 2 of Lanabecestat
Dose 2 of lanabecestat given orally once daily for 156 weeks.
|
Drug: Lanabecestat
Administered orally
Other Names:
|
|
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:
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:
Drug: Placebo
Administered orally
|
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years (Adult, Senior) |
| 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
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
Show 275 Study Locations
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 275 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
Additional Information:
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 ) |
| Study First Received: | May 24, 2016 |
| Last Updated: | August 2, 2017 |
| 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 |
ClinicalTrials.gov processed this record on August 18, 2017