AHEAD Plasma Extension (APEX)
J
Jared Brosch, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
N/A
10 participants needed
1 Location
Brief description of study
What is this study about?
The purpose of this
study is to collect blood-based biomarkers, cognitive assessments and a
self-report of cognitive function annually in a group of cognitively
unimpaired individuals who do not yet show evidence of substantial
amyloid deposition at the time of AHEAD screen failure.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants who have screen failed from the A3-45 study will be approached and contacted by the research team for this study only.
Detailed description of study
The APEX Study is observational, and no treatments will be administered as part of this study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: healthy
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria
- Previously consented to participate in A3-45 screening.
- Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
- If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
- As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures
Exclusion criteria
- Current treatment with an FDA approved medication for Alzheimer’s disease, including prior or current treatment with a prohibited medication as described in section 6.2.1.
- Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five half-lives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm (NOTE: Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval).
- Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).
Updated on
01 Aug 2024.
Study ID: NEUR-USC-APEX, 19674
