Establish Taiwan Alzheimer's Disease Neuroimaging Initiative - a Three-year Pilot Study

Summary

Alzheimer's disease (AD) may be one of the most pressing problems facing all countries around the world as the population ages.AD is a slowly evolving process that likes begins years to decades before the clinical symptoms area manifest. However, as one would like to identify the disease process at an earlier point in the clinical continuum, the precision of the diagnosis is reduced. Therefore, the challenge is to try to identify the process at the pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to characterize subjects at an early clinical phase of AD and subjects with MCI have been a target for prevention trials. There are two pathological landmarks, in terms of extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present symptomatic treatments provide some benefit to patients with AD, they are not the solution for AD. Up to date, there are still no therapies can alter the underlying nature of the AD process. Therefore, the earlier the intervention takes place, presumably, the greater the protection against further neuronal damage will be appreciated.The Alzheimer's Disease Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the United States and Canada established to develop standardized imaging techniques and biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI has been a groundbreaking project, establishing pre-competitive collaboration and real-time data sharing among academia and industry investigators to clarify the relationships among demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout the course of AD neurobiology, in order to facilitate the development of effective therapeutics.This project has exceeded expectations, providing insights into disease mechanisms as well as hugely valuable advances, based primarily on the use of standardized biomarkers, to drug development programs. A number of the leading disease-modifying drug development programs are now employing ADNI methodology toward more efficient trial design, particularly in the critically important early (pre-dementia) AD population

Conditions

• Alzheimer's Disease

Interventions

DRUG

F18-AV45

This study will recruit a total of 200 evaluable subjects (50 cognitively normal volunteers, 100 MCI, and 50 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Tzu-Chen YEN, MD,PhD · Nuclear Medicine

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

55 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• Taiwan

Study Locations