None listed
Conditions
Interventions
Group 1 Type of group
Participants received 60 milligrams (mg) LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Group name:Group 2 Type of group
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
55 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Meets the criteria for probable AD of the National Institute of Neurological and Communication Disorders and Stroke / Association of Alzheimer´s Patients and Related Disorders (NINCDS / ADRDA). • Has a score <4 on the Modified Hachinski Ischemia Scale • Has an MMSE score of 16 to 26 on Visit 1 • Has a score <6 on the Geriatric Depression Scale (GDS) (on the short form administered by the staff). • You have a magnetic resonance imaging (MRI) or computed tomography (CT) scan done within the last 2 years that has been confirmed without results inconsistent with a diagnosis of AD. The results of this MRI or CT must be archived in the center. If a patient has not had an MRI / CT before the study in the last 2 years or attempts to obtain results of historical images are not successful, then a head CT should be performed without contrast of selection; the safeguards due to obtain the results outside the center must be documented in the patient´s file prior to obtaining a head CT without contrast of selection. • You are at least 55 years old. If you are a woman, you must be post-menopausal, (evidenced by absence of menstruation for at least 12 consecutive months or for having had a bilateral oophorectomy.
Exclusion criteria
Exclusion criteria: • Meets the criteria for vascular dementia of the National Institute of Neurological Disorders and Stroke / International Association for Research and Teaching in Neurosciences (NINDS / AIREN) • You do not have a reliable caregiver who is frequently in contact with the patient (defined for at least 10 hours a week), who accompanies the patient to the consultation and / or is available by phone at designated times and who will monitor the administration of prescribed medications Note: The caregiver must be able to communicate with the center staff and be willing to comply with the requirements of the protocol and that in the opinion of the researcher must have an adequate educational level to complete the specific questionnaires of the protocol. Participants who are living in a nursing home can also be included if the intake of the study medication is supervised and if regular contact is maintained with a caregiver who accompanies the patient. • Not able to swallow whole medications. • Have serious or unstable diseases including liver, kidney, gastroenterological, respiratory, cardiovascular (including ischemic), endocrinological, neurological (other than AD), psychiatric, immunological, or hematological disease or other conditions that, in the opinion of the researcher , could interfere with safety and efficacy analyzes in this study or have a life expectancy 458 ms in men or> 474 in women. (See Section 6.3.2.2 for details on the use of QTc for exclusion.) • You have evidence of significant active heart disease, uncontrolled hypertension, decompensated congestive heart failure or endocarditis. • Has a potassium level 2 times the upper limit of normal (ULN) of the laboratory performing the analysis, aspartate transaminase (AST / SGOT) values> 3 times the ULN, or total bilirubin values> 2.0 times the ULN • Requires or is expected to require the use of drugs excluded during the study, in particular calcium channel blockers, specific immunom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimers disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. Measure:Change From Baseline in Alzheimers Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks Timepoints:Baseline (randomization), 76 weeks ; Outcome name:The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimers disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. Measure:Change From Baseline in Alzheimers Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug Timepoints:Baseline (randomization), 16 weeks following treatment cessation ; Outcome name:The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participants caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. Measure:Change From Baseline in Alzheimers Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks Timepoints:Baseline (randomization), 76 weeks ; Outcome name:The ADCS-ADL is a 23-item inventory deve | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:CDR-SB is a semi-structured interview of participants and their caregivers. Participants cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. Measure:Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks Timepoints:Baseline (randomization), 76 weeks ; Outcome name:NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participants behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. Measure:Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks Timepoints:Baseline (randomization), 76 weeks ; Outcome name:Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator. Measure:Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks Timepoints:Baseline (randomization), up to 76 weeks ; Outcome name:EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, sev | — |
Countries
Brazil, Bulgaria, Canada, China, France, Germany, Hungary, Italy, Japan, Korea South, Mexico, Romania, Russian Federation, Serbia, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactGabriela Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed