Mild Cognitive Impairment Clinical Trial
Official title:
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
Status | Completed |
Enrollment | 8 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - An adult between 18 and 85 years of age. - Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5 - Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception). - Able to speak and read English. - Willing to comply with study specific instructions, and complete all study procedures according to protocol. - Able to understand study rationale and sign informed consent. Exclusion Criteria: - Diagnosed with glaucoma - History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide). - Currently taking warfarin and dabigatran (Pradaxa). - History of having arrhythmias - can interfere with EECP triggering. - Subject has bleeding diathesis. - Subject has active thrombophlebitis. - Subject has severe lower extremity vaso-occlusive disease. - Subject has a documented aortic aneurysm requiring surgical repair. - Subject is pregnant. - Subject with blood pressure higher than 180/110 mmHg. - Subject with a heart rate more than 120 bpm. - Subject with high risk of complications from increased venous return. - Subject with clinically significant valvular disease. - Subjects with severe vascular disease as established by the Hachinski Ischemic Index. - Subjects with pacemakers and other metallic implantable devices. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
Patrick Moriarty, MD, FACP, FACC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cognitive Function | Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment). | Baseline, Week 7, 6 Month | No |
Secondary | Change in Ophthalmic blood flow (OBF) | Baseline to Week 7 | No | |
Secondary | Change in Blood Viscosity | Baseline to Week 7 | No | |
Secondary | Cholesterol composition of the blood | Baseline to week 7 | No |
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