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

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)