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Trial record 4 of 11 for:    amaranth

An Efficacy and Safety Study of LY3314814 in Early Alzheimer's Disease (AMARANTH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Eli Lilly and Company
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02245737
First received: September 18, 2014
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to assess the efficacy and safety of LY3314814 compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that LY3314814 is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 LY3314814 treatment groups compared with placebo.

Condition Intervention Phase
Alzheimer´s Disease
Drug: LY3314814
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 104 ]

Secondary Outcome Measures:
  • Change from Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline on the Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 104 ]
  • Time in Clinical Dementia Rating (CDR) Global Score Stage [ Time Frame: Baseline through Loss of 1 Global Stage or Week 104 ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline on the Mini-Mental Status Examination (MMSE) [ Time Frame: Baseline, Week 104 ]
  • Pharmacodynamics (PD): Change from Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 97 ]
  • PD: Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 97 ]
  • Change from Baseline in CSF Total Tau [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline in CSF Phosphorylated Tau [ Time Frame: Baseline, Week 104 ]
  • Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) [ Time Frame: Baseline, Week 104 ]
  • Change From Baseline in Tau PET [ Time Frame: Baseline, Week 104 ]
  • Change From Baseline in PET Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) [ Time Frame: Baseline, Week 104 ]
  • Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 104 ]
  • Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814 [ Time Frame: Week 4 through Week 91 ]
  • Population PK: Central Volume of Distribution of LY3314814 [ Time Frame: Week 4 through Week 91 ]

Estimated Enrollment: 2202
Study Start Date: September 2014
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3314814 20 mg
LY3314814 20 milligrams (mg) given orally once daily for 104 weeks.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Experimental: LY3314814 50 mg
LY3314814 50 mg given orally once daily for 104 weeks.
Drug: LY3314814
Administered orally
Other Name: AZD3293
Placebo Comparator: Placebo
Placebo given orally once daily for 104 weeks.
Drug: Placebo
Administered orally

Detailed Description:
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET scan at screening will be included in the PET-substudy, and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed.
  Eligibility

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

Inclusion Criteria:

  • Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
  • Mini-Mental State Examination score of 20-30 inclusive at screening
  • Objective impairment in memory as evaluated by memory test performed at screening
  • For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
  • For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD

Exclusion Criteria:

  • Significant 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, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
  • History of clinically evident stroke, or multiple strokes based on history or imaging results
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
  • Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or 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 assessments, or affect the participant´s ability to complete the study
  • History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
  • Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
  • Congenital QT prolongation
  • History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
  • Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
  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: NCT02245737

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

  Show 249 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: NCT02245737     History of Changes
Other Study ID Numbers: 16023
I8D-MC-AZES ( Other Identifier: Eli Lilly and Company )
2014-002601-38 ( EudraCT Number )
D5010C00009 ( Other Identifier: AstraZeneca )
Study First Received: September 18, 2014
Last Updated: April 5, 2017
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:
Alzheimer's disease
Dementia
Brain Diseases
Neurogenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies

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 April 28, 2017