The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and 1 control group. The subjects will be randomized in a 1:1:1:1 proportion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
347
Therapeutic plasma exchange with human albumin 5%
Low volume plasma exchange with human albumin 5%
Intravenous human immunoglobulin 5%
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months)
ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.
Time frame: Baseline and 14 months
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months)
ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).
Time frame: Baseline and 14 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northern California Research
Sacramento, California, United States
Mountain View Clinical Research, Inc
Denver, Colorado, United States
Howard University
Washington D.C., District of Columbia, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Largo Medical Center
Largo, Florida, United States
L&L Research Choices, Inc
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
...and 30 more locations