HYBRID EVENT: You can participate in person at Paris, France or Virtually from your home or work.

3rd Edition of Cardiology World Conference

September 14-15, 2022 | Hybrid Event

September 14 -15, 2022 | Paris, France
CWC 2019

Treatment of Mild Cognitive Impairment Due to Alzheimerss Disease or Mild Dementia of Alzheimers Type: Design and Rationale of the Randomized Pivotal Study of RenewTM NCP 5

Patrick M Moriarty, Speaker at Speakers for CWC conference- Patrick M Moriarty
niversity of Kansas Medical Center, Kansas City, KS, United States
Title : Treatment of Mild Cognitive Impairment Due to Alzheimerss Disease or Mild Dementia of Alzheimers Type: Design and Rationale of the Randomized Pivotal Study of RenewTM NCP 5

Abstract:

Background: Vascular dementia and Alzheimer’s disease (AD) share an association with hemodynamic risk factors. Exercise can improve cerebral blood flow (CBF), which is associated with a decrease in cognitive decline. However, patients with AD or mild cognitive impairment (MCI) may have limited exercise capacity due to age-related physical restrictions. RenewTM NCP-5 is an FDA-cleared, external counterpulsation (ECP) device which consistently improves coronary and peripheral vascular hemodynamics by sequential compression and decompression of vascular beds in synchrony with the cardiac cycle (Figure 1), and is currently used to treat patients with chronic angina and congestive heart failure. ECP may provide the same hemodynamic benefit for cerebral perfusion and cognitive function.

Methods: This randomized, Phase 3, pivotal, single-blind, parallel-design, multi-center study (NCT03721705) will assess the efficacy of RenewTM NCP-5 in patients with MCI due to AD or mild dementia (MD) of Alzheimer’s type at 16 sites in the USA, Europe, and Asia. Study participants(see Table 1 for key entry criteria) will be randomized 1:1 to receive a bolus of 35 60-minute RenewTM NCP-5treatment sessions or sham therapy with 3–5 sessions per week. Following the initial 35 treatments, a maintenance period will begin with two treatment sessions per week for up to 24 weeks total. (Figure 2). The primary efficacy endpoint is the average of the change from baseline in Vascular Dementia Assessment Scale cognitive subscale (vADAS-Cog) at Weeks 12, 18, and 24. Safety is assessed throughout the study; other key assessments, including the measurement of CBF as a potential mechanistic index of therapeutic engagement through arterial spin labelling perfusion MRI, are presented in Figure 2. At month 12, all subjects will undergo a full assessment, and the sham group will have the option to enter an open-label extension.

Results: We hypothesise that RenewTM NCP-5 therapy will lead to effective treatment or delay of cognitive impairment in study participants.

Conclusion: This pivotal study aims to evaluate the efficacy and safety of RenewTM NCP-5 as a therapeutic option for patients with MCI due to AD or MD of Alzheimer’s type.

Biography:

Dr. Moriarty is a professor of medicine at the University of Kansas Medical Center and the director of the medical center’s division of Clinical Pharmagology, Atherosclerosis Prevention Clinic and Lipid-apheresis Center in the department of Internal Medicine. Dr. Moriarty has completed over 75 clinical research studies as principal or co-investigator and authored over 100 scientific papers, serves as a key opinion leader in the field of lipidology, and as the past President of the International Society For Apheresis (ISFA) is one of the world’s foremost authorities on lipoprotein apheresis. Dr. Moriarty’s research program includes a variety of clinical trials focused on improving therapeutic options to treat and prevent atherosclerosis, blood rheology, and vascular disease.

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