Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

Lilly

Status and phase

Terminated

Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: Solanezumab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01127633

H8A-MC-LZAO (Other Identifier)

11935

Details and patient eligibility

About

This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).

Enrollment

1,457 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
Must have good vein access to administer infusions
Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion criteria

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study