Clinical Trial 53093

Ocoee, FL 34761


Summary:

Early Alzheimer's Disease

If you or a loved one is experiencing Early Alzheimer's disease, please consider this clinical research study.  

ABOUT THIS STUDY
This study will test how safe and effective a study drug is in men and women age 50-85 with Early Alzheimer’s disease. 

Participants will be randomly placed (like the flip of a coin) into one of four study treatment groups. Three groups will receive a designated dose of the study drug, and the other group will receive a placebo. The placebo looks just like the study drug but contains no active ingredient. The participant, study doctor, study staff, and study partner will not know who is receiving the study drug and who is receiving a placebo.



Criteria:

AM I ELIGIBLE FOR THIS STUDY?
You may qualify to participate in this study if you are 50-85 years old and:
• Have Early Alzheimer’s disease
• Weigh no more than 120 kg (about 265 pounds)
• Have no cognitive condition other than Alzheimer’s
• Do not live in a long-term care or skilled nursing home

This study has additional requirements that the study doctor will discuss with you.

You must also have a caretaker, friend, or family member who has regular in-person contact with you at least 10 hours per week and can be your study partner. This person will attend study visits with you, speak with the study doctor and study  staff about your cognitive and functional abilities, and assist with completing questionnaires.


Qualified Participants May Receive:

STUDY PERIODS
Participants will be in this study for up to about 28 months and visit the study clinic up to about 32 times. This study has three periods:
• Screening (about eight to 11 weeks): A series of tests to see if you qualify for the study. If you agree to participate in optional assessments, you may have a screening period of up to 11 weeks.
• Study treatment (48 to 96 weeks): You will receive the study drug during this period.
• Follow-Up (eight weeks): Two visits to the study center for final tests.

IS THERE A COST TO PARTICIPATE?
The study drug and all study-related procedures will be provided at no charge.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.