Alzheimer’s Disease with Dementia MedDRA version: 19.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: LY3314814 20 mg film-coated tablets
Product Code: LY3314814
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
CAS Number: 1522418-41-2
Current Sponsor code
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3230
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD as compared with placebo in patients with mild AD dementia;Secondary Objective: To evaluate the efficacy of LY3314814 on functional, clinical, and cognitive outcomes in patients with mild AD dementia at the end of the Placebo-Controlled period (week 78). To evaluate the relationship between treatment effect of LY3314814 and time. To test the hypothesis that LY3314814 will slow the rate of cognitive and functional decline associated with AD, compared with placebo To evaluate the efficacy of LY3314814 to prolong time in the current disease state To evaluate the effect of LY3314814 on CSF Aß PD markers, CSF markers of neurodegeneration, brain amyloid burden, regional cerebral blood flow, brain aggregated tau levels, brain Metabolism and brain Atrophy;Primary end point(s): Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score ;Timepoint(s) of evaluation of this end point: 78 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score • Change from Baseline in Functional Activities Questionnaire (FAQ) Score • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score • Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score • Change in Clinical Dementia Rating (CDR) Global Score • Change from Baseline in Neuropsychiatric Inventory (NPI) Score • Change from Baseline on the Mini-Mental State Examination (MMSE) • Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aß1-42 • Change from Baseline in Concentration of CSF Biomarker Aß1-40 • Change from Baseline in CSF Biomarker Total Tau • Change from Baseline in CSF Biomarker Phosphorylated Tau • Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan • Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan • Change from Baseline in Whole Brain Volume • Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814 • Population PK: Central Volume of Distribution of LY3314814 ;Timepoint(s) of evaluation of this end point: Timeframe for most endpoints is 78 weeks from baseline Exception is Population (PK) - Pre-dose week 4 through week 71 | — |
Countries
Canada, China, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed