Mild Alzheimer's Disease MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: Solanezumab
Product Code: LY2062430
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Solanezumab
Current Sponsor code: LY2062430
Concentration unit: mg milligram(s)
Concen
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD. [2] Has a Modified Hachinski Ischemia Scale score of less than or equal to 4. [3] Has an MMSE score of 20 through 26 at Visit 1 (Screening visit). [4] Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form). [5] Has had an MRI or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD. [6] Male or female patients ages 55 to 90 years old. [7] Has a florbetapir PET scan or CSF result consistent with the presence of amyloid pathology at screening. 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 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1680
Exclusion criteria
Exclusion criteria: [1] Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications. [2] Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l’Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia. [3] Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years. [4] Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness. [5] Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment. [6] Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions [7] Has received AChEIs, memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments [8] Has received medications that affect the central nervous system (CNS), except treatments for AD for less than 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that solanezumabwill slow the cognitive decline of AD as compared with placebo in patients with mild AD. ;Secondary Objective: • To test the hypothesis that solanezumab will slow the functional decline of AD as compared with placebo in patients with mild AD • To assess the relationship between treatment effect and time. • To test the hypothesis that solanezumab will slow the rate of cognitive and functional decline associated with AD assessed using a slope analysis from a repeated-measures model.;Primary end point(s): ADAS-Cog14 ;Timepoint(s) of evaluation of this end point: Week 0, 12, 28, 40, 52, 64, 80 and Early Discontinuation Visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD, EQ-5D Proxy, ADCS-iADL and the iADRS . ;Timepoint(s) of evaluation of this end point: Week 0, 28, 52, 80 and Early Discontinuation Visits | — |
Countries
France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed