Early Alzheimer’s Disease Study
Protocol: SITE00000136
Full Title
Assessment of Safety, Tolerability, and Efficacy ofDonanemabin Early Symptomatic Alzheimers Disease I5T-MC-AACI
Description
This study enrolls older adults who have had changes in memory. The purpose of this study is to learn whether the study medication, donanemab, can slow the progression of Early Alzheimer’s Disease.

You will be in this study for up to 2.5 years. During the study you will have a variety of imaging scans, physical exams, blood/urine samples, and complete questionnaires. For up to 72 weeks you will take either Donanemab given as an intravenous (IV) infusion or a placebo. A placebo is an IV infusion with no active ingredients. The group you are in will be picked by random chance, like flipping a coin. Study visits take place at UBMD neurology clinics.

Technical Description

Study AACI is a multicenter, randomized, double-blind placebo-controlled, Phase 2 study of donanemab in participants with early symptomatic AD. Participants who meet entry criteria will be randomized in a 1:1 ratio to 1 of the following treatment groups:
Donanemab: 1400 mg IV Q4W
Placebo
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 60-85.
Have had gradual, progressive changes in memory.
Age Group: Adults
Principal Investigator: KINGA SZIGETI
Contact(s)
CONNIE BRAND
conniebr@buffalo.edu
+1 716-323-0549
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.