Early Alzheimer's Disease (mild cognitive impairment due to AD (ie, prodromal AD) and mild dementia of the Alzheimer's type) MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: LY3314814
Product Code: LY3314814
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Yet Available
Current S
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed start I8D-MC-AZFD 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 285 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1115
Exclusion criteria
Exclusion criteria: Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate disease modification as outlined in Liu-Seifert (2015). This will be accomplished by testing the three delayed-start hypotheses in both doses of LY3314814 across Study AZES and up to Week 26 (Visit 7) of Study AZFD. ; Secondary Objective: 1. To evaluate the disease modification of both doses of LY3314814 on functional and cognitive outcomes across Study AZES and up to Week 26 (Visit 7) of Study AZFD using the primary analysis methodology. 2. The delayed start analyses as outlined above will also be examined at Week 104 (Visit 15) for cognitive and functional outcomes. 3. Collect information in order to further characterize the safety and tolerability of LY3314814 in patients with early AD dementia (at the time of entry into Study AZES) ; Primary end point(s): 1. Delayed start analysis on the ADAS-Cog13 ; Timepoint(s) of evaluation of this end point: 1. V. 5, 7, and at early discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Delayed start analysis on the ADCS-iADL 2. Delayed start analysis on the FAQ 3. Delayed start analysis on the iADRS 4. Delayed start analysis on the MMSE 5. Delayed start analysis on the ADAS-Cog13 Standard safety assessments: 6. Spontaneously reported AEs 7. Clinical laboratory tests 8. Vital signs 9. Body weight 10. 12-lead ECGs 11. Physical examinations including neurological examinations ? Additional safety assessments: 12. Eye examinations 13. Skin examinations 14. Serial MRI 15. Columbia-Suicide Severity Rating Scale (C-SSRS) ; Timepoint(s) of evaluation of this end point: 1. V. 7, 11, 13, 15 & early discontinuation 2. V. 7, 11, 13, 15 & early discontinuation 3. V. 7, 11, 13, 15 & early discontinuation 4. V. 5, 7, 11, 13, 15 & early discontinuation 5. V. 5, 7, 11, 13, 15 & early discontinuation 6, As observed 7. V. 3, 4, 5, 7, 9, 11, 12, 13, 14, 15 & early discontinuation 8. V. 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 & early discontinuation & follow-up 9 V. 5, 7, 11, 15 & early discontinuation 10. V. 2, 3, 5, 7, 9, 11, 13, 15 &early discontinuation& follow-up 11. V. 3, 5, 7, 9, 11, 12, 13, 14, 15 &early discontinuation 12. V. 11, 15 & early discontinuation 13. V. 5, 11, 15 early discontinuation 14. V. 11, 15 & early discontinuation 15. V. 2, 3, 4, 5, 6, 7, 9, 10, 11,12, 13, 14, 15 & early discontinuation&follow-up | — |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Romania, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed