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Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

2014-08-27 03:13:09 | BioPortfolio

Summary

The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease

Description

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

Acronyms are listed in the secondary outcome section. Below you will find a list of the acronyms defined.

- MMSE - Mini Mental Status Exam

- QoL-AD - Quality of Life - Alzheimer's Disease

- CIBIC-plus - Clinician Interview - Based Impression of Change

- NPI - Neuropsychiatric Inventory

- CSDD - The Cornell Scale for Depression in Dementia

- ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Additional oversight authorities are:

- United Kingdom EC: Multicentre Research Ethics Committee (MREC)

- Russia EC: Ethics Committee Under the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation

- Ukraine EC: Central Ethic Commission of Ministry of Health of Ukraine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Alzheimer's Disease

Intervention

ABT-384, donepezil, placebo

Location

Bath
United Kingdom
BA1 3NG

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:09-0400

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