NCT01659398

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

August 3, 2012

Last Update Submit

January 12, 2016

Conditions

Mild Cognitive Impairment

Keywords

Alzheimer's Diseasecerebral blood flowophthalmic blood flowblood viscosity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Ophthalmic blood flow (OBF)

    Baseline to Week 7

  • Change in Blood Viscosity

    Baseline to Week 7

  • Cholesterol composition of the blood

    Baseline to week 7

Study Arms (2)

Enhanced external counterpulsation (EECP)

EXPERIMENTAL
Device: External Counterpulsation (EECP)

Subjects not receiving EECP

NO INTERVENTION

Control group to measure data from experimental group against.

Interventions

External Counterpulsation (EECP)DEVICE

A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.

Enhanced external counterpulsation (EECP)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Interventions

Counterpulsation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Assisted CirculationSurgical Procedures, Operative

Study Officials

  • Patrick Moriarty, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Clinical Pharmacology

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)