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

Lilly

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Solanezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760602

2016-000108-27 (EudraCT Number)

16349

H8A-MC-LZBE (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

26 participants in 2 patient groups

Solanezumab

Experimental group

Description:

Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.

Treatment:

Drug: Solanezumab

Placebo

Experimental group

Description:

Placebo given IV once every 4 weeks for up to 2 years.

Treatment:

Drug: Placebo