A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

Key facts

Study ID

NCT02760602

Run by

Eli Lilly and Company

People needed

26

Starts

2016-06-01

Expected to finish

2017-05-01

Last updated by the study team

2019-10-10

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
• Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
• Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
• Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
• Scores >0 on the Functional Activities Questionnaire (FAQ).
• Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.

You may not qualify if…

• Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
• Has known allergy to humanized monoclonal antibodies.
• Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
• Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
• Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
• Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• St Josephs Hospital and Medical Center — Phoenix, 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
• Parexel Early Phase Unit at Glendale — Glendale, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• Desert Valley Research — Rancho Mirage, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Care Access Research LLC — Santa Clarita, California, United States
• California Neuroscience Research — Sherman Oaks, California, United States
• Care Access Research — Valencia, California, United States
• MCB Clinical Research Centers — Colorado Springs, Colorado, United States
• Mile High Research Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Christiana Care Research Institute — Newark, Delaware, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• Sunrise Clinical Research — Hollywood, Florida, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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