Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments solanezumab, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date July 2013
End date October 2016
Trial size 2100 participants
Trial identifier NCT01900665, 15136, H8A-MC-LZAX

Summary

To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
solanezumab LY2062430
Administered Intravenously (IV)
(Placebo Comparator)
Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
placebo
Administered IV

Primary Outcomes

Measure
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
time frame: Baseline, Week 80

Secondary Outcomes

Measure
Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
time frame: Baseline, Week 80
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
time frame: Baseline, Week 80
Change from Baseline in Mini-Mental State Examination (MMSE)
time frame: Baseline, Week 80
Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
time frame: Baseline, Week 80
Change from Baseline in Functional Activities Questionnaire (FAQ)
time frame: Baseline, Week 80
Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
time frame: Baseline, Week 80
Change from Baseline in Neuropsychiatric Inventory (NPI)
time frame: Baseline, Week 80
Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)
time frame: Baseline, Week 80
Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)
time frame: Baseline, Week 80
Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)
time frame: Baseline, Week 80
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
time frame: Baseline, Week 80
Proportion of Cognitive and Functional Responders
time frame: Baseline through Week 80
Change from Baseline in Plasma Amyloid-Beta (Aβ) Species
time frame: Baseline, Week 80
Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI)
time frame: Baseline, Week 80
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)
time frame: Baseline through Week 80
Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan
time frame: Baseline, Week 80
Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels
time frame: Baseline, Week 80

Eligibility Criteria

Male or female participants from 55 years up to 90 years old.

Inclusion Criteria: - Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD - Has a Modified Hachinski Ischemia Scale score of less than or equal to 4 - Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit - Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form) - Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD - Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening Exclusion Criteria: - Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications - Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia - 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 - 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 - 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 - Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions - Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments - Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks - Has a history of chronic alcohol or drug abuse/dependence within the past 5 years

Additional Information

Official title Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.