Baseline neuroimaging characteristics in the randomized pivotal study of renew NCP‐5 for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia of the Alzheimer's type

Abstract

AbstractBackgroundRenew NCP‐5 is an FDA‐cleared, external counterpulsation (ECP) device used clinically to improve coronary and peripheral vascular hemodynamics by sequential compression and decompression of vascular beds in synchrony with the cardiac cycle. NCP‐5 treatment may have a beneficial effect on disorders of blood flow including mild cognitive impairment (MCI) and Alzheimer’s disease (AD). We describe here the baseline neuroimaging characteristics of the participants from a randomized pivotal study of Renew NCP‐5 for the treatment of MCI due to AD or mild dementia of the Alzheimer's type.MethodNeuroimaging was conducted across ten sites in the United States for safety screening, baseline imaging assessment including disease severity, and for acquisition of exploratory neuroimaging markers of treatment modification. Imaging protocols were based on the cross‐platform protocols developed for the Alzheimer's Disease Neuroimaging Initiative (ADNI3). Participant characterization and exploratory outcome neuroimaging measures included T1‐weighted hippocampal volume and arterial spin labeling‐based measures of cerebral blood flow (CBF).ResultBaseline structural data were acquired in 97 participants in the NCP‐5 group, and 89 participants in the active sham group. ASL data were available on a subset of scanners and acquired in 60 participants in the NCP‐5 group and 48 participants in the active sham group. Baseline neuroimaging assessment revealed expected variation with age and disease severity in the total cohort. A difference in baseline hippocampal volume and CBF was detected between the randomized groups with the NCP‐5 group having reduced measures (reduced hippocampal volume and reduced CBF) compared to the active sham group. These effects were apparent when splitting the treatment groups by disease severity and cardiovascular risk.ConclusionWe present here the baseline characteristics for the participant cohort for the randomized pivotal study of Renew NCP‐5 for the treatment of MCI due to AD or mild dementia of the Alzheimer's type. Imaging measures were in accord with expected directional effects for age and for disease. There was an unexpected difference between the NCP‐5 treatment and active sham group at baseline with the NCP‐5 group having greater neurodegeneration. Longitudinal imaging data are being examined in ongoing work.