Design Considerations for Secondary Prevention Trials in Alzheimer's Disease

• Activity Number: 223
• Type: Topic Contributed
• Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Ronald Thomas*+
• Companies: ADCS Data Core
• Keywords: power ; prevention ; alzheimers

Abstract

A growing consensus exists among leading Alzheimer's Disease (AD) researchers that intervention needs to be applied earlier in the disease's pre-clinical phase than previously thought. The current thinking is that one reason AD clinical trials over the last 20 years have been almost universally negative is that intervention in the prodromal or later phases of disease is too late, i.e. the damage done to the brain at that point is irreversible.

Over the last several years considerable discussion has taken place among AD research thought leaders as to how best to design trials of therapeutic agents in the pre-clinical phase, i.e. where risk is evident but before symptoms are evident.

This presentation will discuss current approaches to secondary prevention trials in AD, in particular the specific issues of defining eligibility and efficacy measures.

Regarding target population: Two main approaches have emerged, one focuses on indivs w/ gene mutations that place them at risk for familial AD. A second determines risk through the measurement of amyloid in the brain via the use of PET imaging or measured in CSF

Effective response measures need to be sensitive to subtle changes.