Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01900665

Run by

Eli Lilly and Company

People needed

2129

Starts

2013-07-01

Expected to finish

2017-02-01

Last updated by the study team

2019-10-09

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Has a Visit 1 MRI with results showing >4 Amyloid-related Imaging Abnormality (ARIA), -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• St Josephs Hospital and Medical Center — Phoenix, Arizona, United States
• ANI Arizona Neurological Institute Research, PC — Sun City, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• Arizona Health Sciences Center — Tucson, Arizona, United States
• American Neuropsychiatric Research Institute, Inc — Carson, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Institute for Memory Impairment & Neurological Disorders — Irvine, California, United States
• University of California - San Diego — La Jolla, California, United States
• Senior Clinical Trials, Inc. — Laguna Hills, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Collaborative Neuroscience Network - CNS — Long Beach, California, United States
• Apostle Clinical Trials, Inc — Long Beach, California, United States
• Univ of Southern California Medical Center — Los Angeles, California, United States
• University of California Los Angeles School of Medicine — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• Anderson Clinical Research — Redlands, California, United States
• University of California, Davis - Health Systems — Sacramento, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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