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Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer's Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm
Date:8/26/2013

p="name">Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. "TOMMORROW is a significant study and represents a novel clinical milestone and trial for the Alzheimer's community as it evaluates pre-symptomatic patients."

About the TOMMORROW Trial
The TOMMORROW trial is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The trial will use a genetic–based biomarker risk assignment algorithm comprised of APOE and TOMM40 genotypes and age, which is being studied to determine the risk of individuals developing MCI due to AD within a five year period. Cognitively normal individuals assessed as low risk will be assigned to receive placebo. Cognitively normal individuals assessed as high risk will be assigned to AD-4833 or placebo. The study duration is approximately five years or the time needed to achieve 410 conversions to MCI due to AD in the high risk group. Approximately 5,800 cognitively normal individuals aged 65-83 at 50 centers worldwide will be randomized into the study. The study will recruit internationally from large, diverse, community-based populations.

The study has two objectives:

For the genetic-based biomarker risk assignment algorithm, the primary objective is to qualify the risk assignment algorithm for identification of subjects at high risk of developing MCI due to AD within the next five years. The primary endpoint for the risk assignment algorithm is time to diagnosis of MCI due to AD for placebo-treated, high-risk subjects versus placebo-treated, low-risk subjects.

For AD-4833, considered an investigational drug for this use, the primary objective is to evaluate the efficacy of AD-4833 versus placebo in delaying the onset of MCI due to AD in cognitively normal individuals assessed as high risk based on the risk assignment algorithm. The primary endpoint is time to diagnosis of MCI due to AD for AD-4833-treated subjects versus pl
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SOURCE Takeda Pharmaceutical Company Limited
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