In order to determine if NfL can be a prognostic biomarker for VCID, participants will
undergo a baseline evaluation consisting of neuropsychological testing and a blood draw with
a 12-month follow-up consisting of neuropsychological testing and blood draw. After indicated
interest in the study, participants will be screened either in person during a regularly
scheduled clinic visit or by phone for eligibility. After consenting, participants will be
scheduled for a baseline testing session. One session, lasting about 3 hrs, will include
neuropsychological testing and a blood draw. After completion of baseline testing,
participants who agree to take part in the clinical trial will begin a 12-week treatment of
Ang-(1-7) via daily subcutaneous injections. During the drug treatment, participants will be
called weekly to ensure that everything is going well with the injections. After participants
have completed the 12-week injection period, participants will be scheduled for a second
appointment which will include a blood draw and neuropsychological testing. All participant
will be scheduled for a 12-month follow-up, which will include a blood draw and
neuropsychological testing. Participants will be called every second month by research staff
for a brief update on changes to health status, and to increase compliance with the 12-month
follow-up.
Our One-Year outcome for this study is to provide early proof-of-concept clinical trial data
that will support a larger, more comprehensive NIH funded study on the safety and efficacy of
Ang-(1-7) to prevent cognitive impairment in HF patients at risk for developing VCID/ADRD.
Our Long-Term outcome is to demonstrate whether plasma NfL exhibits characteristics making it
useful as a Prognostic Biomarker to predict cognitive decline in early heart
disease-associated VCID and identify pre VCID-symptomatic in individuals with symptomatic HF.
Our goal will be to use levels of plasma Nfl as an enrollment enrichment factor in future
trials to allow enrollment or stratification of patients more likely to develop VCID or ADRD
and be responsive to Ang-(1-7) therapy.