NCT02008357

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,169 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease \[AD\]).

Detailed description

The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque build-up in their brains who may be at risk for memory loss and cognitive decline due to Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or dementia with the aim of slowing memory and cognitive decline. The A4 study will also test whether anti-amyloid treatment can delay the progression of AD related brain injury on imaging and other biomarkers.

Conditions

• Cognition Disorders

Interventions

Type	Name	Description
DRUG	Placebo	Administered IV
DRUG	Solanezumab	Administered IV

Timeline

• Start date: 2014-02-28
• Primary completion: 2022-12-27
• Completion: 2023-06-08
• First posted: 2013-12-11
• Last updated: 2023-12-28
• Results posted: 2023-12-28

Locations

68 sites across 4 countries: United States, Australia, Canada, Japan

Regulatory

• FDA-regulated drug study