> Skip repeated content

HSS Research Institute

A Novel Phase 2 Double-Blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Centrally Acting, Non-Toxic ACE Inhibition in Cognitive Impairment Associated with SLE

IRB Number: 2020-0226

Institutional Review Board, Hospital for Special Surgery

February 15, 2022

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

David R. Fernandez, MD, PhD
Jeffrey Zhang-Sun

Summary

In earlier pre-clinical and clinical studies, researchers have found evidence that treatment with brain-acting ACE inhibitors is associated with reduced brain inflammation and reduced brain cell loss. This improvement was reflected by reduced regional hypermetabolism as observed by PET imaging of the brain. This study is evaluating the efficacy and safety of treatment with a brain-acting ACE inhibitor in patients with lupus to reduce brain hypermetabolism as measured by PET imaging and to improve cognitive function as measured by neuropsychological testing.

Patients will be randomized 1:1 to receive either lisinopril, a brain-acting ACE inhibitor, or benazepril, a non-brain-acting ACE inhibitor, by mouth for the duration of the study. It is anticipated that 6-7 patients will be enrolled at HSS and a total of 36 patients will be enrolled across all study sites until the end of 2022.

At HSS visits, study participants can expect a medical assessment, vital sign measurements, SLE disease activity assessments, patient surveys, and blood and urine studies. Patients will need to go to the Feinstein Institutes for Medical Research up to 4 times over the entire duration of study (at most 421 days) for imaging studies (PET and optional MRI) and neuropsychological assessments. Study participants will be compensated for their time and reimbursed for study-related expenses.
 

Inclusion/Exclusion Criteria

1.    ≥18 and ≤55 years of age

2.    Fulfills either the 1997 ACR, SLICC, or 2019 EULAR/ACR SLE classification criteria

3.    No increase in disease activity for last 4 weeks, stable DMARDs for last 4 weeks, and at most 10mg prednisone equivalent

4.    No history of severe CNS manifestations (i.e. severe head injury, stroke, seizure, dementia, etc) or other primary psychiatric disorder requiring medication (diagnosed pre-SLE)

5.    No rituximab for 6 months (belimumab is allowed if stable for 4 months)

6.    No current use of an ACE inhibitor or angiotensin receptor blocker or use for more than 4 weeks in the last year

7.    No current use of anxiolytic, anticonvulsant, antidepressant or antipsychotic medications

8.    Cannot be pregnant or lactating or planning to become pregnant
 

Contact Information


Jeffrey Zhang-Sun
Research Coordinator
zhangsunj@hss.edu
212.774.2967