[Registries to Boost the Clinical Trials for the Disease Modifying Therapy of Alzheimer's Disease].

The development of disease-modifying therapies (DMT) for Alzheimer's disease (AD) is an urgent goal worldwide. Since the first clinical trial of Abeta immunization therapy in 2001, a number of trials targeting early-stage AD dementia have failed. Researchers now believe that DMT must be initiated much earlier than in these failed trials, i.e., at the preclinical or prodromal stages of AD. This notion is supported by AD biomarker studies, which have revealed that Abeta and tau accumulation appears 10 to 30 years prior to the occurrence of dementia and propagates gradually in the brain to a symptomatic level. However, clinical trials that involve people without dementia have a number of difficulties in the recruitment of participants. The trial sites are required to perform outreach procedures to find potential participants. The AD biomarker tests are either costly or invasive, and the rate of biomarker-positive subjects in the non-demented population is low, suggesting a high screening failure rate. Preclinical AD registries are a possible solution to overcome such difficulties. These registries pool non-demented individuals who are interested in AD clinical research and collect information on demographics and the presence or absence of genetic, lifestyle, and other risk factors. A number of these registries have been established in the United States. An internet-based registry, IROOP, was launched in Japan in 2016.